Trial Outcomes & Findings for Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma (NCT NCT03836053)

NCT ID: NCT03836053

Last Updated: 2025-09-11

Results Overview

DLTs were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with the exception of cytokine release syndrome (CRS) and tumor lysis syndrome (TLS), which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008 respectively. A participant was non-DLT evaluable if they dropped out before completion of the DLT-evaluable period for reasons other than a DLT.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 23 participants
• Primary outcome timeframe: Day 1 to Week 4
• Results posted on: 2025-09-11

Participant Flow

This study was conducted at 10 centers in Australia, Belgium, Japan, Switzerland, and the United States from 04 March 2019 to 21 April 2022.

23 participants were enrolled and all 23 of those participants received study drug.

Participant milestones

Measure	AMG 420 200 µg/Day 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Overall Study STARTED	1	12	10
Overall Study COMPLETED	0	2	0
Overall Study NOT COMPLETED	1	10	10

Reasons for withdrawal

Measure	AMG 420 200 µg/Day 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Overall Study Protocol-specified criteria	0	2	1
Overall Study Death	1	6	4
Overall Study Withdrawal of consent from study	0	0	1
Overall Study Decision by sponsor	0	2	4

Baseline Characteristics

Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	Total n=23 Participants Total of all reporting groups
Age, Continuous	49.0 years STANDARD_DEVIATION NA • n=5 Participants	64.7 years STANDARD_DEVIATION 6.7 • n=7 Participants	60.8 years STANDARD_DEVIATION 11.7 • n=5 Participants	62.3 years STANDARD_DEVIATION 9.5 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 4

Population: DLT evaluation analysis set includes participants who completed the DLT evaluable period or experienced a DLT any time during the DLT evaluable period.

DLTs were graded using Common Terminology Criteria for Adverse Events (CTCAE) v5.0, with the exception of cytokine release syndrome (CRS) and tumor lysis syndrome (TLS), which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008 respectively.

A participant was non-DLT evaluable if they dropped out before completion of the DLT-evaluable period for reasons other than a DLT.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=11 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=8 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Number of Participants With Dose-limiting Toxicities (DLTs)	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set defined as all participants that are enrolled and receive at least 1 dose of AMG 420.

The severity of TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008. Any clinically significant changes in vital signs, electrocardiograms (ECGs) and clinical laboratory tests were recorded as TEAEs.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	1 Participants	12 Participants	10 Participants

PRIMARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set defined as all participants that are enrolled and receive at least 1 dose of AMG 420.

The severity of treatment-related TEAEs were graded using the CTCAE version 5.0 with the exception of CRS and TLS, which graded using the criteria referenced in the publication by Lee et al, 2014 and the Cairo Bishop criteria referenced in the publication by Coiffier et al, 2008.

Treatment-related TEAEs were those that were considered related to the study treatment by the investigator.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Number of Participants Who Experienced a Treatment-related TEAE	1 Participants	12 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.

ORR was defined as the percentage of participants for whom the best overall response was a stringent complete response (CR), CR, very good partial response (PR), or partial response as determined by the IMWG Uniform Response Criteria. The ORR along with the associated 95% exact binomial confidence interval (Clopper Pearson Method) was determined.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Overall Response Rate (ORR)	0 Percentage of participants Interval 0.0 to 97.5	41.7 Percentage of participants Interval 15.17 to 72.33	30.0 Percentage of participants Interval 6.67 to 65.25

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420. DOR was only calculated for participants who experienced a best overall response of partial response or better.

DOR was defined as number of months between first objective response to progressive disease or death (due to any cause), whichever occurred first.

Kaplan-Meier methods were used to estimate the distribution of DOR. The median and corresponding two-sided 95% confidence intervals were calculated.

Outcome measures

Measure	AMG 420 200 µg/Day 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=5 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=3 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Duration of Response (DOR)	—	5.49 Months Interval 1.41 to Not enough responses to calculate upper limit of 95% CI	NA Months Interval 1.45 to Not enough responses to calculate a median or upper limit of 95% CI

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.

MRD negativity at CR or better assessed by using the IMWG criteria.

Percentage of MRD negative responders at CR along with exact 2- sided 95% were provided by using the Clopper Pearson method.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Percentage of Participants With Minimal Residual Disease (MRD) Negativity Response at CR	0.0 Percentage of participants Interval 0.0 to 97.5	8.3 Percentage of participants Interval 0.21 to 38.48	10.0 Percentage of participants Interval 0.25 to 44.5

SECONDARY outcome

Timeframe: Up to approximately 3 years

Population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.

Number of participants with MRD negativity at CR or better assessed by using the IMWG criteria.

Outcome measures

Measure	AMG 420 200 µg/Day n=1 Participants 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 Participants 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 Participants 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation
Number of Participants With Minimal Residual Disease (MRD) Negativity Response at CR	0 Participants	1 Participants	1 Participants

Adverse Events

AMG 420 200 µg/Day

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

AMG 420 400 µg/Day

Serious events: 10 serious events

Other events: 12 other events

Deaths: 6 deaths

AMG 420 600 µg/Day

Serious events: 8 serious events

Other events: 10 other events

Deaths: 4 deaths

Total

Serious events: 19 serious events

Other events: 23 other events

Deaths: 11 deaths

Serious adverse events

Measure	AMG 420 200 µg/Day n=1 participants at risk 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 participants at risk 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 participants at risk 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	Total n=23 participants at risk AMG 420 Total
Nervous system disorders Headache	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Asthenia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Disease progression	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Fatigue	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Pyrexia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Immune system disorders Cytokine release syndrome	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	41.7% 5/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	34.8% 8/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Bacteraemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Device related infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Influenza	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Infusion site infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Sepsis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Staphylococcal sepsis	100.0% 1/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	100.0% 1/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Presyncope	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Vascular disorders Hypotension	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.

Other adverse events

Measure	AMG 420 200 µg/Day n=1 participants at risk 28 day continuous intravenous infusion of AMG 420 200 µg/day followed by a 2 week treatment-free interval, until progressive disease (PD) or relapse as defined by International Myeloma Working Group (IMWG) response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 400 µg/Day n=12 participants at risk 28 day continuous intravenous infusion of AMG 420 400 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	AMG 420 600 µg/Day n=10 participants at risk 28 day continuous intravenous infusion of AMG 420 600 µg/day followed by a 2 week treatment-free interval, until PD or relapse as defined by IMWG response criteria, unacceptable safety events, next anti-multiple myeloma treatment, or other reason for permanent treatment discontinuation	Total n=23 participants at risk AMG 420 Total
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	33.3% 4/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	40.0% 4/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	34.8% 8/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Hyperfibrinogenaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Leukocyte vacuolisation	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Neutrophilia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Cardiac disorders Tachycardia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Eye disorders Cataract	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Eye disorders Conjunctival haemorrhage	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Eye disorders Diplopia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Eye disorders Vision blurred	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Constipation	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	25.0% 3/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	50.0% 5/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	34.8% 8/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Lip dry	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Nausea	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	41.7% 5/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	34.8% 8/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Oral pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Chest discomfort	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Chest pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Chills	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Fatigue	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	41.7% 5/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	60.0% 6/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	47.8% 11/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Hypothermia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Malaise	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Oedema	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Oedema peripheral	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Peripheral swelling	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Pyrexia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	50.0% 6/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	60.0% 6/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	52.2% 12/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
General disorders Ulcer	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Immune system disorders Cytokine release syndrome	100.0% 1/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	75.0% 9/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	70.0% 7/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	73.9% 17/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Bronchitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Clostridium difficile colitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Metapneumovirus infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Nasopharyngitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Oral candidiasis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Rhinitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Rhinovirus infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Sinusitis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Staphylococcal sepsis	100.0% 1/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	33.3% 4/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Urinary tract infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Urinary tract infection bacterial	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Fibula fracture	100.0% 1/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Blood creatine increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Blood creatinine increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Blood fibrinogen increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations C-reactive protein increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Carbon dioxide decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Electrocardiogram T wave abnormal	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Fibrin D dimer increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Immature granulocyte count increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Lipase increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Lymphocyte count decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Neutrophil count decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Nitrite urine present	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Platelet count decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Protein total increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Weight decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations Weight increased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Investigations White blood cell count decreased	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Alkalosis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Gout	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	40.0% 4/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	40.0% 4/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	26.1% 6/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	25.0% 3/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Aphasia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Dizziness	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	30.0% 3/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	21.7% 5/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Dysgeusia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Headache	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	66.7% 8/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	40.0% 4/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	52.2% 12/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Neuralgia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Presyncope	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Seizure	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Sinus headache	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Nervous system disorders Tremor	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Psychiatric disorders Confusional state	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Psychiatric disorders Disorientation	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Psychiatric disorders Insomnia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Psychiatric disorders Nervousness	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Psychiatric disorders Substance abuse	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	16.7% 2/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	17.4% 4/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	0.00% 0/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	4.3% 1/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Vascular disorders Hypertension	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	10.0% 1/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.7% 2/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.
Vascular disorders Hypotension	0.00% 0/1 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	8.3% 1/12 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	20.0% 2/10 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.	13.0% 3/23 • Up to approximately 3 years Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug. All-cause mortality is reported for all participants enrolled in the study.

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