Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies (NCT NCT03465540)

NCT ID: NCT03465540

Last Updated: 2023-04-12

Results Overview

DLTs were defined as specific adverse events (AEs) that occurred in a participant during the DLT evaluation period (Day 1 to Day 28), that the investigator assessed as related to AMG 397. The grading and severity of AEs were based on the guidelines provided in the common terminology criteria for adverse events (CTCAE) version 4.03.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 24 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2023-04-12

Participant Flow

Participants were enrolled at 11 research centers in Australia, France, Greece and the United States from 17 August 2018 to 25 July 2019.

Parts 2 and 3 of the trial were not initiated after part 1 data was reviewed. No participants were screened or enrolled for parts 2 or 3.

Participant milestones

Measure	Part 1a: 80 mg AMG 397 Participants with relapsed/refractory (RR) multiple myeloma (MM) and/or non-Hodgkin's lymphoma (NHL) received 80 mg AMG 397 once a day for 2 consecutive days followed by a 5 day break at a weekly interval (QD2), as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 Participants with RR acute myeloid leukemia (AML) received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Study STARTED	2	6	4	4	5	3
Overall Study Received AMG 397	2	6	4	4	5	3
Overall Study COMPLETED	1	2	1	1	1	1
Overall Study NOT COMPLETED	1	4	3	3	4	2

Reasons for withdrawal

Measure	Part 1a: 80 mg AMG 397 Participants with relapsed/refractory (RR) multiple myeloma (MM) and/or non-Hodgkin's lymphoma (NHL) received 80 mg AMG 397 once a day for 2 consecutive days followed by a 5 day break at a weekly interval (QD2), as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 Participants with RR acute myeloid leukemia (AML) received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Study Withdrawal by Subject	0	0	1	1	1	0
Overall Study Lost to Follow-up	0	1	0	0	1	0
Overall Study Death	1	1	0	2	0	2
Overall Study Protocol specified criteria	0	2	2	0	2	0

Baseline Characteristics

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies

Baseline characteristics by cohort

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Total n=24 Participants Total of all reporting groups
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Preterm newborn infants (gestational age < 37 wks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Infants and toddlers (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Adolescents (12-17 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Adults (18-64 years)	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants
Age, Customized From 65-84 years	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	15 Participants n=8 Participants
Age, Customized 85 years and over	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	11 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	13 Participants n=8 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	22 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized 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	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	18 Participants n=8 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. DLT evaluable set: All participants who experienced a DLT or who received at least 75% of the planned dose in the DLT window (Day 1 to Day 28).

DLTs were defined as specific adverse events (AEs) that occurred in a participant during the DLT evaluation period (Day 1 to Day 28), that the investigator assessed as related to AMG 397. The grading and severity of AEs were based on the guidelines provided in the common terminology criteria for adverse events (CTCAE) version 4.03.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=4 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=3 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=3 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=3 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=2 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

A TEAE was defined as any AE starting on or after the first dose of investigational product. Any clinically significant changes in vital signs, physical examinations, electrocardiogram (ECGs) and clinical laboratory test results were recorded as AEs. The grading and severity of adverse events were based on the guidelines provided in the CTCAE version 4.03. Treatment-related TEAEs were any events that the investigator assessed as related to AMG 397.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) TEAEs	2 Participants	6 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) Treatment-related TEAEs	2 Participants	6 Participants	4 Participants	2 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with MM were only enrolled in part 1a, so therefore data is only presented for part 1a. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

ORR was assessed for participants with MM using response criteria per International Myeloma Working Group (IMWG).

ORR was defined as the percentage of participants who experienced either one of the following based on investigator assessment:

• partial response (PR)
• very good partial response (VGPR)
• complete response (CR)
• stringent complete response (sCR)

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=1 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=5 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Response Rate (ORR) for Participants With Multiple Myeloma (MM)	0.0 Percentage of participants Interval 0.0 to 97.5	0.0 Percentage of participants Interval 0.0 to 52.18	0.0 Percentage of participants Interval 0.0 to 60.24	—	—	—

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with NHL were only enrolled in part 1a, so therefore data is only presented for part 1a. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

ORR was assessed for participants with NHL using response criteria per Lugano Classification.

ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment:

• partial metabolic response/ PR
• complete metabolic response/ CR

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=1 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=1 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Response Rate (ORR) for Participants With Non-Hodgkin's Lymphoma (NHL)	100.0 Percentage of participants Interval 2.5 to 100.0	0.0 Percentage of participants Interval 0.0 to 97.5	—	—	—	—

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Participants with AML were only enrolled in part 1b, so therefore data is only presented for part 1b. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

ORR was assessed for participants with AML using response criteria per European Leukemia Network Response Criteria.

ORR was defined as the percentage of participants who experienced either of the following based on investigator assessment:

• PR
• morphological leukemia-free state (MLFS)
• complete remission with incomplete hematologic recovery (CRi)
• complete remission
• complete remission without minimal residual disease (CRmrd-).

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=4 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=5 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=3 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Response Rate (ORR) for Participants With Acute Myeloid Leukemia (AML)	0.0 Percentage of participants 95% Confidence Interval 0.00 • Interval 0.0 to 60.24	0.0 Percentage of participants 95% Confidence Interval 0.00 • Interval 0.0 to 52.18	0.0 Percentage of participants 95% Confidence Interval 0.00 • Interval 0.0 to 70.76	—	—	—

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the statistical analysis plan (SAP), PFS was only to be calculated if the number of participants who experienced events (disease progression or death) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

PFS was calculated as time from first dose of investigational product date to disease progression date or death due to any cause, whichever was earlier.

PFS time in months: (date of disease progression or death - first dose date +1)/30.4.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Progression-free Survival (PFS)	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the SAP, OS was only to be calculated if the number of participants who experienced an event (death) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

OS was defined as the time from first dose of investigational product date until death due to any cause.

OS time in months: (date of death - first dose date +1)/30.4.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Overall Survival (OS)	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the SAP, TTR was only to be calculated if the number of participants who experienced an event (objective response) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

TTR was defined as the time from the first dose of investigational product until the first documentation of objective response. Only participants who achieved an objective response were evaluated for TTR.

TTR time in months: (date of the first observation of response - first dose of IP date +1)/30.4.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Time to Response (TTR)	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.

SECONDARY outcome

Timeframe: Up to end of study (a maximum of 48 weeks)

Population: Parts 2 and 3 were not initiated and did not enrol any participants, therefore results presented only included participants in part 1. Per the SAP, DOR was only to be calculated if the number of participants who experienced an event (objective response) was 10 or more in either part 1 or part 2. FAS: All participants who were enrolled and received at least 1 dose of AMG 397.

DOR was only planned to be calculated for participants who achieved response (PR or better). DOR was defined as time from the first observation indicating a response to the subsequent date of disease progression or death, whichever was earlier.

DOR time in months: (date of disease progression or death - date of the first observation of response +1)/30.4.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Duration of Response (DOR)	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.	NA Months No data are available due to low event rate in the population.

SECONDARY outcome

Timeframe: Cycle 1 (cycle = 28 days): Predose, 1, 2, 3, 5, 8 & 12 hours postdose on Day 1; predose, 1, 2, 3, 5, 8, 12, 24 & 48 hours postdose on Day 2

Population: The Pharmacokinetic (PK) Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.

Predose data for Day 2 were analyzed/included with the Day 1 data.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Maximum Observed Concentration (Cmax) of AMG 397 Day 1	0.415 µg/mL Geometric Coefficient of Variation 0.470 • Interval 0.47 to 9.999	0.468 µg/mL Geometric Coefficient of Variation 0.606 • Interval 0.606 to	0.908 µg/mL Geometric Coefficient of Variation 1.19 • Interval 1.19 to	0.747 µg/mL Geometric Coefficient of Variation 0.785 • Interval 0.785 to	1.31 µg/mL Geometric Coefficient of Variation 1.87 • Interval 1.87 to	2.51 µg/mL Geometric Coefficient of Variation 2.83 • Interval 2.83 to
Maximum Observed Concentration (Cmax) of AMG 397 Day 2	1.17 µg/mL Geometric Coefficient of Variation 1.29 • Interval 1.29 to	1.80 µg/mL Geometric Coefficient of Variation 1.88 • Interval 1.88 to	2.822 µg/mL Geometric Coefficient of Variation 3.17 • Interval 3.17 to	1.41 µg/mL Geometric Coefficient of Variation 1.51 • Interval 1.51 to	3.69 µg/mL Geometric Coefficient of Variation 4.46 • Interval 4.46 to	4.57 µg/mL Geometric Coefficient of Variation 5.14 • Interval 5.14 to

SECONDARY outcome

Timeframe: Cycle 1 (cycle = 28 days): Predose, 1, 2, 3, 5, 8 & 12 hours postdose on Day 1; predose, 1, 2, 3, 5, 8, 12, 24 & 48 hours postdose on Day 2

Population: The PK Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.

Predose data for Day 2 were analyzed/included with the Day 1 data.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Time to Maximum Observed Concentration (Tmax) for AMG 397 Day 1	12 Hours Full Range 12 • Interval 12.0 to 12.0	18 Hours Full Range 8.0 • Interval 8.0 to 24.0	8.1 Hours Full Range 5.1 • Interval 5.1 to 12.0	12 Hours Full Range 8.1 • Interval 8.1 to 24.0	21 Hours Full Range 7.8 • Interval 7.8 to 25.0	12 Hours Full Range 11 • Interval 11.0 to 12.0
Time to Maximum Observed Concentration (Tmax) for AMG 397 Day 2	4 Hours Full Range 2.9 • Interval 2.9 to 5.1	8.3 Hours Full Range 7.9 • Interval 7.9 to 12.0	7.9 Hours Full Range 4.9 • Interval 4.9 to 8.2	6.6 Hours Full Range 5.0 • Interval 5.0 to 8.1	7.2 Hours Full Range 3.3 • Interval 3.3 to 8.5	8.1 Hours Full Range 8.0 • Interval 8.0 to 12.0

SECONDARY outcome

Timeframe: Cycle 1 (cycle = 28 days): Predose, 3, 5, & 8 hours postdose on days 1 (12 hours postdose on Day 1 only), 8 & 15, predose & 8 hours postdose on Day 22 & days 2, 3, 4, 9, 16, 17, 18 & 23; Cycles 2, 3 & 4 (cycle = 28 days): Predose on days 2, 8, 15 & 22

Population: The PK Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Area Under the Concentration Time Curve From Time 0 to 168 Hours (AUC0-168) for AMG 397	635 hr*µg/mL Geometric Coefficient of Variation 70.8 • Interval 70.8 to	115 hr*µg/mL Geometric Coefficient of Variation 123 • Interval 123.0 to	230 hr*µg/mL Geometric Coefficient of Variation 266 • Interval 266.0 to	108 hr*µg/mL Geometric Coefficient of Variation 115 • Interval 115.0 to	264 hr*µg/mL Geometric Coefficient of Variation 306 • Interval 306.0 to	227 hr*µg/mL Geometric Coefficient of Variation 444 • Interval 444.0 to

SECONDARY outcome

Timeframe: Cycle 1 (cycle = 28 days): Predose, 3, 5, & 8 hours postdose on days 1 (12 hours postdose on Day 1 only), 8 & 15, predose & 8 hours postdose on Day 22 & days 2, 3, 4, 9, 16, 17, 18 & 23; Cycles 2, 3 & 4 (cycle = 28 days): Predose on days 2, 8, 15 & 22

Population: The PK Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Clearance (CL) of AMG 397	1.08 L/hr Geometric Coefficient of Variation 1.13 • Interval 1.13 to	1.17 L/hr Geometric Coefficient of Variation 1.21 • Interval 1.21 to	1.02 L/hr Geometric Coefficient of Variation 1.42 • Interval 1.42 to	0.449 L/hr Geometric Coefficient of Variation 0.488 • Interval 0.488 to	0.563 L/hr Geometric Coefficient of Variation 0.674 • Interval 0.674 to	0.320 L/hr Geometric Coefficient of Variation 0.467 • Interval 0.467 to

SECONDARY outcome

Timeframe: Cycle 1 (cycle = 28 days): Predose, 3, 5, & 8 hours postdose on days 1 (12 hours postdose on Day 1 only), 8 & 15, predose & 8 hours postdose on Day 22 & days 2, 3, 4, 9, 16, 17, 18 & 23; Cycles 2, 3 & 4 (cycle = 28 days): Predose on days 2, 8, 15 & 22

Population: The PK Analysis Set: All participants who received at least 1 dose of AMG 397 and had at least 1 PK sample collected.

Outcome measures

Measure	Part 1a: 80 mg AMG 397 n=2 Participants Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 Participants Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 Participants Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 Participants Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 Participants Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 Participants Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Half-life (t1/2) of AMG 397	60.1 hours Geometric Coefficient of Variation 62.8 • Interval 62.8 to	49.7 hours Geometric Coefficient of Variation 54.9 • Interval 54.9 to	76.9 hours Geometric Coefficient of Variation 90.1 • Interval 90.1 to	96.3 hours Geometric Coefficient of Variation 118 • Interval 118.0 to	53.4 hours Geometric Coefficient of Variation 55.1 • Interval 55.1 to	109 hours Geometric Coefficient of Variation 129 • Interval 129.0 to

Adverse Events

Part 1a: 80 mg AMG 397

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1a: 160 mg AMG 397

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Part 1a: 320 mg AMG 397

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1b: 80 mg AMG 397

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

Part 1b: 160 mg AMG 397

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1b: 320 mg AMG 397

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part 1a: 80 mg AMG 397 n=2 participants at risk Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 participants at risk Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 participants at risk Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 participants at risk Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 participants at risk Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 participants at risk Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Gastritis erosive	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Gastrointestinal toxicity	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Haematemesis	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Ileus	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Melaena	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Mouth ulceration	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Nausea	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Asthenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Fatigue	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Aspergillus infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Coronavirus infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Lymph gland infection	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Pneumonia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Troponin T increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Troponin increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypercalcaemia	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	66.7% 2/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Presyncope	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Renal and urinary disorders Acute kidney injury	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Renal and urinary disorders Chronic kidney disease	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Vascular disorders Haematoma	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.

Other adverse events

Measure	Part 1a: 80 mg AMG 397 n=2 participants at risk Participants with RR MM and/or NHL received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 160 mg AMG 397 n=6 participants at risk Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1a: 320 mg AMG 397 n=4 participants at risk Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 80 mg AMG 397 n=4 participants at risk Participants with RR AML received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 160 mg AMG 397 n=5 participants at risk Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.	Part 1b: 320 mg AMG 397 n=3 participants at risk Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 2/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	83.3% 5/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	75.0% 3/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Cardiac disorders Bundle branch block right	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Cardiac disorders Sinus tachycardia	100.0% 2/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Cardiac disorders Supraventricular extrasystoles	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Cardiac disorders Tachycardia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Eye disorders Dry eye	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	40.0% 2/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Constipation	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Diarrhoea	100.0% 2/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	66.7% 4/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	75.0% 3/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	80.0% 4/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	100.0% 3/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Dysphagia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Melaena	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Mouth ulceration	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Nausea	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	83.3% 5/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	75.0% 3/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	80.0% 4/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Oral blood blister	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Plicated tongue	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Gastrointestinal disorders Vomiting	100.0% 2/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	66.7% 4/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	75.0% 3/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	80.0% 4/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Asthenia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Chest pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Chills	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Fatigue	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 3/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Non-cardiac chest pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Oedema peripheral	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
General disorders Pyrexia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Immune system disorders Drug hypersensitivity	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Arthritis bacterial	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Bacteraemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Bacterial infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Clostridium difficile infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Fungal infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Pneumonia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Rhinitis	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Staphylococcal infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Urinary tract infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Urinary tract infection bacterial	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Vascular device infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Infections and infestations Wound infection	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Contusion	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Haemodilution	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Limb injury	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Periorbital haematoma	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Injury, poisoning and procedural complications Wound	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Alanine aminotransferase increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Blood creatinine increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Liver function test abnormal	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Neutrophil count decreased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Troponin increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Urine output decreased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Weight decreased	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 2/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations Weight increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Investigations White blood cell count increased	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 2/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	75.0% 3/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Fluid overload	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hyperglycaemia	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 2/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypophagia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	50.0% 2/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Dizziness	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Dizziness postural	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Headache	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Hypogeusia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Lethargy	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Nervous system disorders Somnolence	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Psychiatric disorders Insomnia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Renal and urinary disorders Dysuria	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Renal and urinary disorders Haematuria	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	80.0% 4/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	16.7% 1/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Erythema	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	33.3% 1/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Vascular disorders Hypertension	0.00% 0/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.
Vascular disorders Hypotension	50.0% 1/2 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/6 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	25.0% 1/4 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	20.0% 1/5 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.	0.00% 0/3 • Mortality data are reported up to end of study (a maximum of 48 weeks); Adverse events are reported from Day 1 up to 30 days after last dose (Maximum time on treatment was 18 weeks for part 1a and 13 weeks for part 1b) All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for the FAS.

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