Trial Outcomes & Findings for Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012) (NCT NCT00931606)

Last Updated: 2023-09-13

Results Overview

Hematopoietic response rate is defined as the percentage of participants who had increase in hemoglobin concentration of ≥ 1 g/dL relative to baseline for 28 consecutive days during the treatment period including up to 2 months after the last dose of study treatment in the absence of red blood cell (RBC) transfusion or treatment with an erythropoiesis-stimulating agent (ESA). The percentage of participants who achieved hematopoietic response is presented.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Baseline and Up to ~145 Days

Results posted on

2023-09-13

Participant Flow

This study was terminated early after 30 participants were enrolled due to slower than expected rate of enrollment as a result of changes in guidance for the treatment of participants with breast cancer and chemotherapy induced anemia (CIA).

Participant milestones

Participant milestones
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo Participants received placebo subcutaneously every 28 days up to 4 doses.
Overall Study STARTED	8	10	7	5
Overall Study COMPLETED	3	1	1	2
Overall Study NOT COMPLETED	5	9	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo Participants received placebo subcutaneously every 28 days up to 4 doses.
Overall Study Death	1	3	2	0
Overall Study Lost to Follow-up	0	1	0	0
Overall Study Physician Decision	0	0	3	0
Overall Study Sponsor Decision	1	4	0	2
Overall Study Withdrawal by Subject	3	1	1	1

Baseline Characteristics

Study of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer (MK-7962-012)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sotatercept 0.1 mg/kg n=8 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	Total n=30 Participants Total of all reporting groups
Age, Continuous	51.6 Years STANDARD_DEVIATION 9.38 • n=5 Participants	50.8 Years STANDARD_DEVIATION 8.51 • n=7 Participants	55.6 Years STANDARD_DEVIATION 12.53 • n=5 Participants	49.2 Years STANDARD_DEVIATION 10.62 • n=4 Participants	51.9 Years STANDARD_DEVIATION 9.83 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	30 Participants n=21 Participants
Sex: Female, Male Male	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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	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
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) 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
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Weight	67.38 Kilograms STANDARD_DEVIATION 18.338 • n=5 Participants	71.80 Kilograms STANDARD_DEVIATION 9.500 • n=7 Participants	69.94 Kilograms STANDARD_DEVIATION 9.953 • n=5 Participants	79.62 Kilograms STANDARD_DEVIATION 9.926 • n=4 Participants	71.49 Kilograms STANDARD_DEVIATION 12.647 • n=21 Participants
Chemotherapy Frequency Weekly	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Chemotherapy Frequency Less Frequently	6 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=5 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=9 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=4 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants n=18 Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Percentage of Participants Who Achieved a Hematopoietic Response Overall	0 Percentage of Participants Interval 0.0 to 52.2	33.3 Percentage of Participants Interval 7.5 to 70.1	50.0 Percentage of Participants Interval 6.8 to 93.2	20.0 Percentage of Participants Interval 0.5 to 71.6	27.8 Percentage of Participants Interval 9.7 to 53.5
Percentage of Participants Who Achieved a Hematopoietic Response Received weekly chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 84.2	0 Percentage of Participants Interval 0.0 to 84.2	25.0 Percentage of Participants Interval 2.5 to 100.0	20 Percentage of Participants Interval 2.5 to 100.0	5.6 Percentage of Participants Interval 0.5 to 71.6
Percentage of Participants Who Achieved a Hematopoietic Response Received less frequent chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 70.8	33.3 Percentage of Participants Interval 9.9 to 81.6	25.0 Percentage of Participants Interval 0.8 to 90.6	0 Percentage of Participants Interval 0.0 to 60.2	22.2 Percentage of Participants Interval 9.1 to 61.4

SECONDARY outcome

Timeframe: Up to ~175 Days

Population: All participants who received at least one dose of study intervention.

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced AEs is reported.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=8 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Number of Participants Who Experienced an Adverse Event (AE)	6 Participants	7 Participants	7 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Up to ~85 Days

Population: All participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=8 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event	1 Participants	0 Participants	4 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study treatment for at least 2 months (57 days).

Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL for 28 consecutive days is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=5 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=9 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=4 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants n=18 Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL Overall	0 Percentage of Participants Interval 0.0 to 52.2	11.1 Percentage of Participants Interval 0.3 to 48.2	0 Percentage of Participants Interval 0.0 to 60.2	0 Percentage of Participants Interval 0.0 to 52.2	5.6 Percentage of Participants Interval 0.1 to 27.3
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL Received weekly chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 84.2	0 Percentage of Participants Interval 0.0 to 84.2	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 52.2
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥ 2 g/dL Received less frequent chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 70.8	11.1 Percentage of Participants Interval 0.4 to 57.9	0 Percentage of Participants Interval 0.0 to 70.8	0 Percentage of Participants Interval 0.0 to 60.2	5.6 Percentage of Participants Interval 0.2 to 36.0

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).

Percentage of participants achieving hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 11 g/dL for 28 consecutive days is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=5 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=9 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=4 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants n=18 Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL Overall	20.0 Percentage of Participants Interval 0.5 to 71.6	22.2 Percentage of Participants Interval 2.8 to 60.0	75.0 Percentage of Participants Interval 19.4 to 99.4	20.0 Percentage of Participants Interval 0.5 to 71.6	33.3 Percentage of Participants Interval 13.3 to 59.0
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL Received weekly chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 84.2	11.1 Percentage of Participants Interval 1.3 to 98.7	25.0 Percentage of Participants Interval 2.5 to 100.0	20.0 Percentage of Participants Interval 2.5 to 100.0	11.1 Percentage of Participants Interval 5.3 to 85.3
Percentage of Participants Achieving an Increase From Baseline Hemoglobin ≥ 11 g/dL Received less frequent chemotherapy and showed a response	20.0 Percentage of Participants Interval 0.8 to 90.6	11.1 Percentage of Participants Interval 0.4 to 57.9	50.0 Percentage of Participants Interval 9.4 to 99.2	0 Percentage of Participants Interval 0.0 to 60.2	22.2 Percentage of Participants Interval 9.1 to 61.4

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).

Percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days during the treatment period and up to 2 months after the last dose of study treatment in the absence of RBC transfusion or treatment with an ESA. The percentage of participants achieving an increase from baseline hemoglobin of ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL for 28 consecutive days is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=5 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=9 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=4 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants n=18 Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL Overall	20.0 Percentage of Participants Interval 0.5 to 71.6	22.2 Percentage of Participants Interval 2.8 to 60.0	75.0 Percentage of Participants Interval 19.4 to 99.4	20.0 Percentage of Participants Interval 0.5 to 71.6	33.3 Percentage of Participants Interval 13.3 to 59.0
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL Received weekly chemotherapy and showed a response	0 Percentage of Participants Interval 0.0 to 84.2	11.1 Percentage of Participants Interval 1.3 to 98.7	25.0 Percentage of Participants Interval 2.5 to 100.0	20.0 Percentage of Participants Interval 2.5 to 100.0	11.1 Percentage of Participants Interval 5.3 to 85.3
Percentage of Participants Achieving an Increase From Baseline Hemoglobin of ≥2 g/dL and/or Hemoglobin ≥ 11 g/dL Received less frequent chemotherapy and showed a response	20.0 Percentage of Participants Interval 0.8 to 90.6	11.1 Percentage of Participants Interval 0.4 to 57.9	50.0 Percentage of Participants Interval 9.4 to 99.2	0 Percentage of Participants Interval 0.0 to 60.2	22.2 Percentage of Participants Interval 9.1 to 61.4

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥1 g/dL and less than 2 g/dL increase from baseline.

Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 1 g/dL from baseline to the last time there is hemoglobin ≥ 1 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for ≥ 1 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=3 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Duration of Hematopoietic Response for Hemoglobin ≥ 1 g/dL	—	47.0 Days Standard Deviation 20.30	46.5 Days Standard Deviation 14.85	29.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥2 g/dL and less than 11 g/dL increase from baseline.

Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 2 g/dL from baseline to the last time there is hemoglobin ≥ 2 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=1 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Duration of Hematopoietic Response for Hemoglobin ≥ 2 g/dL	—	69.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	—	—	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days), and had a hematopoietic response of ≥11 g/dL increase from baseline.

Duration of hematopoietic response is defined as the time period from the first time hemoglobin increases at least ≥ 11 g/dL from baseline to the last time there is hemoglobin ≥ 11 g/dL increase from baseline. Duration of response is only calculated for a responder and will be at least 28 days. The duration of response is only calculated for a patient who meets the primary efficacy endpoint. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=1 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Duration of Hematopoietic Response for Hemoglobin ≥ 11 g/dL	—	41.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	50.0 Days Standard Deviation 9.90	29.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 1 g/dL and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 1 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=3 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 1 g/dL and/or Hemoglobin Concentration ≥ 11 g/dL	—	47.0 Days Standard Deviation 20.30	50.0 Days Standard Deviation 9.90	29.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.

Duration of hematopoietic response is defined as the time period the first time hemoglobin increases ≥ 2 g/dL, and/or hemoglobin concentration is ≥ 11 g/dL from baseline to the last time when the same response is maintained. The data for duration of response for hemoglobin ≥ 2 g/dL and/or hemoglobin concentration ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=1 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Duration of Hematopoietic Response for Hemoglobin Increases ≥ 2 g/dL, and/or Hemoglobin Concentration ≥ 11 g/dL	—	69.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	50.0 Days Standard Deviation 9.90	29.0 Days Standard Deviation NA NA = Standard deviation cannot be calculated for 1 participant.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Time to achieve hematopoietic response based on ≥ 1 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 1 g/dL that was maintained for at least 28 consecutive days. The data for time to achieve hematopoietic response for hemoglobin ≥ 1 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=3 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 1 g/dL Increase From Baseline	—	NA Days Interval 72.0 to NA = Not estimable due to small number of responses.	NA Days Interval 6.0 to NA = Not estimable due to small number of responses.	NA Days Interval 112.0 to NA = Not estimable due to small number of responses.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Time to achieve hematopoietic response based on ≥ 2 g/dL increase from baseline, is defined as the time from first dose of study treatment to the first hemoglobin increase ≥ 2 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 2 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=1 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 2 g/dL Increase From Baseline	—	NA Days NA = Not estimable due to small number of responses.	—	—	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had hematopoietic response of ≥ 11 g/dL increase from baseline.

Time to achieve hematopoietic response based on hemoglobin ≥ 11 g/dL, defined as the time from first dose of study treatment to the first hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=1 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=2 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=3 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time to Achieve Hematopoietic Response of Hemoglobin ≥ 11 g/dL From Baseline	NA Days Interval 28.0 to NA = Not estimable due to small number of responses.	NA Days Interval 100.0 to NA = Not estimable due to small number of responses.	56.0 Days Interval 6.0 to NA = Not estimable due to small number of responses.	NA Days Interval 112.0 to NA = Not estimable due to small number of responses.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 1 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.

Time to achieve hematopoietic response based on multiple criteria categories, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 1 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 1 g/dL and/or ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=1 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=4 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=3 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 1 g/dL and/or Hemoglobin ≥ 11 g/dL	NA Days Interval 28.0 to NA = Not estimable due to small number of responses.	NA Days Interval 21.0 to NA = Not estimable due to small number of responses.	56.0 Days Interval 6.0 to NA = Not estimable due to small number of responses.	NA Days Interval 112.0 to NA = Not estimable due to small number of responses.	—

SECONDARY outcome

Timeframe: Baseline and Up to ~145 Days

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a hematopoietic response of ≥ 2 g/dL and/or hemoglobin concentration is ≥11 g/dL increase from baseline.

Time to achieve hematopoietic response, defined as the time from first dose of study treatment to first hemoglobin increase ≥ 2 g/dL and/or hemoglobin ≥ 11 g/dL that was maintained for at least 28 consecutive days. The data for duration of response for hemoglobin increase from baseline ≥ 2 g/dL and/or ≥ 11 g/dL from baseline is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=1 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=2 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=3 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=1 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Time to Achieve Hematopoietic Response of First Hemoglobin Increase ≥ 2 g/dL and/or Hemoglobin ≥ 11 g/dL	NA Days Interval 28.0 to NA = Not estimable due to small number of responses.	NA Days NA = Not estimable due to small number of responses.	56.0 Days Interval 6.0 to NA = Not estimable due to small number of responses.	NA Days Interval 112.0 to NA = Not estimable due to small number of responses.	—

SECONDARY outcome

Timeframe: Up to Day 141

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention and on study intervention for at least 2 months (57 days).

The percentage of participants who received RBC transfusion or treatment with an ESA in each study treatment group as well as within each cycle of each study treatment is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=5 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=9 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=4 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Overall RBC Transfusions	0 Percentage of Participants	33.3 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Overall ESAs	0 Percentage of Participants	11.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Overall Received RBC Transfusions or ESAs	0 Percentage of Participants	44.4 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 1 to Prior to Day 29 RBC Transfusions	0 Percentage of Participants	11.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 1 to Prior to Day 29 ESAs	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 1 to Prior to Day 29 Received RBC Transfusions or ESAs	0 Percentage of Participants	11.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 29 to Prior to Day 57 RBC Transfusions	0 Percentage of Participants	22.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 29 to Prior to Day 57 ESAs	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 29 to Prior to Day 57 Received RBC Transfusions or ESAs	0 Percentage of Participants	22.2 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 57 to Prior to Day 85 RBC Transfusions	0 Percentage of Participants	0 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 57 to Prior to Day 85 ESAs	0 Percentage of Participants	11.1 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 57 to Prior to Day 85 Received RBC Transfusions or ESAs	0 Percentage of Participants	11.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 85 to Prior to Day 141 RBC Transfusions	0 Percentage of Participants	11.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 85 to Prior to Day 141 ESAs	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Percentage of Participants Who Received RBC Transfusion or Treatment With an ESA Day 85 to Prior to Day 141 Received RBC Transfusions or ESAs	0 Percentage of Participants	11.1 Percentage of Participants	25.0 Percentage of Participants	0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Baseline and Day 64

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.

ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants who experienced a CR or PR at Day 64 is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=4 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=6 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=4 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Complete Response	0 Percentage of Participants	33.3 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Partial Response	0 Percentage of Participants	16.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Stable Disease	100.0 Percentage of Participants	16.7 Percentage of Participants	100.0 Percentage of Participants	50.0 Percentage of Participants	—
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Progressive Disease	0 Percentage of Participants	16.7 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Not Evaluable	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Response Rate (ORR) for Target Lesions at Day 64 Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1). Not Applicable	0 Percentage of Participants	16.7 Percentage of Participants	0 Percentage of Participants	50.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Day 64

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=4 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=6 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=2 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=4 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. Complete Response	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. Progressive Disease	50.0 Percentage of Participants	33.3 Percentage of Participants	0 Percentage of Participants	50.0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. Non-complete Response/Non-progressive disease	50.0 Percentage of Participants	50.0 Percentage of Participants	100.0 Percentage of Participants	25.0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. Not Evaluable	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions at Day 64 Using RECIST v 1.1. Not Applicable	0 Percentage of Participants	16.7 Percentage of Participants	0 Percentage of Participants	25.0 Percentage of Participants	—

SECONDARY outcome

Timeframe: Day 113

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=2 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=2 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=1 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=3 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Complete Response	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Partial Response	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Stable Disease	100.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	33.3 Percentage of Participants	—
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Progressive Disease	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Not Evaluable	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Target Lesions on Day 113 Using RECIST v 1.1. Not Applicable	0 Percentage of Participants	100.0 Percentage of Participants	100.0 Percentage of Participants	66.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Day 113

Population: All randomized participants who have confirmed CIA, received at least one dose of study intervention, on study intervention for at least 2 months (57 days) and had a response.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=2 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=2 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=1 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=3 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. Complete Response	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. Progressive Disease	0 Percentage of Participants	0 Percentage of Participants	100.0 Percentage of Participants	33.3 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. Non-complete Response/Non-progressive disease	100.0 Percentage of Participants	50.0 Percentage of Participants	0 Percentage of Participants	33.3 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. Not Evaluable	0 Percentage of Participants	50.0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	—
Objective Tumor Response Rate for Non-target Lesions on Day 113 Using RECIST v 1.1. Not Applicable	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	33.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: From start of chemotherapy (which could have occurred prior to study start) up to Study Day 281

Population: All randomized participants who received at least one dose of study intervention.

PFS was defined as the time from start of the chemotherapy regimen (which could have occurred prior to study start and collected as prior anticancer therapy) to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Sotatercept 0.1 mg/kg n=8 Participants Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 Participants Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 Participants Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 Participants Participants received placebo subcutaneously every 28 days up to 4 doses.	All Sotatercept-treated Participants n=25 Participants Participants received sotatercept at one of the following doses: 0.1 mg/kg, 0.3 mg/kg, or 0.5 mg/kg subcutaneously every 28 days up to 4 doses.
Progression-free Survival (PFS)	188.0 Days Interval 64.0 to 188.0	196.0 Days Interval 97.0 to 219.0	187.0 Days Interval 134.0 to 1791.0	157.0 Days Interval 84.0 to NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.	169.0 Days Interval 108.0 to 219.0

Adverse Events

Sotatercept 0.1 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 1 deaths

Sotatercept 0.3 mg/kg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 3 deaths

Sotatercept 0.5 mg/kg

Serious events: 3 serious events

Other events: 7 other events

Deaths: 3 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Total

Serious events: 6 serious events

Other events: 25 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Sotatercept 0.1 mg/kg n=8 participants at risk Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 participants at risk Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 participants at risk Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 participants at risk Participants received placebo subcutaneously every 28 days up to 4 doses.	Total n=30 participants at risk Total for all participants
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Nausea	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Peptic ulcer	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Vomiting	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Asthenia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Fatigue	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Anorexia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Syncope	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Vascular disorders Hypotension	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.

Other adverse events

Other adverse events
Measure	Sotatercept 0.1 mg/kg n=8 participants at risk Participants received sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.3 mg/kg n=10 participants at risk Participants received sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses.	Sotatercept 0.5 mg/kg n=7 participants at risk Participants received sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses.	Placebo n=5 participants at risk Participants received placebo subcutaneously every 28 days up to 4 doses.	Total n=30 participants at risk Total for all participants
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	30.0% 3/10 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	23.3% 7/30 • Number of events 7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Blood and lymphatic system disorders Leukopenia	37.5% 3/8 • Number of events 8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	40.0% 2/5 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	16.7% 5/30 • Number of events 12 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Blood and lymphatic system disorders Neutropenia	50.0% 4/8 • Number of events 9 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	60.0% 3/5 • Number of events 7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	30.0% 9/30 • Number of events 19 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 2/8 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 6 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	13.3% 4/30 • Number of events 10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Cardiac disorders Nodal arrhythmia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Cardiac disorders Supraventricular tachycardia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Cardiac disorders Tachycardia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Eye disorders Conjunctivitis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Ascites	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 2/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Constipation	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	40.0% 2/5 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	13.3% 4/30 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Gastric ulcer	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Nausea	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	60.0% 3/5 • Number of events 5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 6/30 • Number of events 12 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Oral discomfort	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Oral pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Peritoneal effusion	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Pneumoperitoneum	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Stomatitis	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Gastrointestinal disorders Vomiting	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	42.9% 3/7 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	16.7% 5/30 • Number of events 6 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Asthenia	37.5% 3/8 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 2/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	40.0% 2/5 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	30.0% 9/30 • Number of events 12 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Chest pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	40.0% 2/5 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 6/30 • Number of events 6 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Generalised oedema	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Hyperthermia	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Influenza like illness	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Local swelling	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Oedema peripheral	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
General disorders Pyrexia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Hepatobiliary disorders Liver disorder	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Clostridial infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Helicobacter infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Paronychia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Respiratory tract infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Staphylococcal infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Streptococcal infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Urinary tract infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Device migration	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Blood albumin decreased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Blood creatinine increased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Prothrombin time prolonged	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Skin turgor decreased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Staphylococcal identification test positive	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Urine output decreased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Vitamin D decreased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Investigations Weight decreased	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Anorexia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Metabolism and nutrition disorders Malnutrition	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 2/10 • Number of events 5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	13.3% 4/30 • Number of events 7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	30.0% 3/10 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	13.3% 4/30 • Number of events 4 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to gastrointestinal tract	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Coma	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Convulsion	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Disturbance in attention	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 2/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Dizziness	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Dyskinesia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Encephalopathy	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	40.0% 2/5 • Number of events 5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	16.7% 5/30 • Number of events 8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Hemiparesis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Hypersomnia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Neuropathy peripheral	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Paraesthesia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Nervous system disorders Unresponsive to stimuli	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Psychiatric disorders Confusional state	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Psychiatric disorders Delirium	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Psychiatric disorders Insomnia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Dysuria	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Enuresis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Haematuria	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Polyuria	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Renal and urinary disorders Renal failure acute	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Reproductive system and breast disorders Breast mass	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Reproductive system and breast disorders Breast pain	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 3/30 • Number of events 3 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Skin and subcutaneous tissue disorders Dermatitis allergic	12.5% 1/8 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	14.3% 1/7 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 2/10 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Vascular disorders Flushing	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	10.0% 1/10 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Vascular disorders Hypertension	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Vascular disorders Hypotension	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	28.6% 2/7 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/5 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	6.7% 2/30 • Number of events 2 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.
Vascular disorders Lymphoedema	0.00% 0/8 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/10 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	0.00% 0/7 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	20.0% 1/5 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.	3.3% 1/30 • Number of events 1 • Up to Day 281 The safety analysis population included all participants who received at least one dose of study treatment. The analysis population for All-Cause Mortality included all allocated participants.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information concerning Sotatercept is considered confidential and shall remain the sole property of the Sponsor. No publication or disclosure of study results will be permitted except as specified in a separate, written, agreement between the Sponsor and the Investigator.
Publication restrictions are in place

Restriction type: OTHER