Trial Outcomes & Findings for An Extension Study of Bomedemstat (IMG-7289/MK-3543) in Participants With Myeloproliferative Neoplasms (IMG-7289-CTP-202/MK-3543-005) (NCT NCT05223920)

NCT ID: NCT05223920

Last Updated: 2025-09-22

Results Overview

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 81 participants
• Primary outcome timeframe: Up to ~32 months
• Results posted on: 2025-09-22

Participant Flow

Participants with Myeloproliferative Neoplasms (MPNs) who participated in a prior bomedemstat study such as, but not limited to, IMG-7289-CTP-102/MK-3543-002 (NCT03136185) and IMG-7289-CTP-201/MK-3543-003 (NCT04254978) (referred to hereafter as 'feeder studies') were included in the recruitment.

Participants were assigned to either the Essential thrombocythemia (ET) arm or Myelofibrosis (MF) arm based on prior diagnosis.

Participant milestones

Measure	Essential Thrombocythemia (ET) Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Overall Study STARTED	52	29
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	52	29

Reasons for withdrawal

Measure	Essential Thrombocythemia (ET) Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Overall Study Adverse Event	6	3
Overall Study Death	2	0
Overall Study Disease Progression	1	2
Overall Study Physician Decision	1	2
Overall Study Sponsor decision	11	9
Overall Study Transferred to Extension Study MK-3543-017 (NCT06351631)	29	7
Overall Study Subject decision	1	0
Overall Study Withdrawal by Subject	1	6

Baseline Characteristics

Analysis population contained all MF participants who had baseline measurement.

Baseline characteristics by cohort

Measure	Essential Thrombocythemia (ET) n=52 Participants Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 Participants Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Total n=81 Participants Total of all reporting groups
Age, Continuous	65.8 Years STANDARD_DEVIATION 11.01 • n=52 Participants	65.3 Years STANDARD_DEVIATION 9.68 • n=29 Participants	65.6 Years STANDARD_DEVIATION 10.49 • n=81 Participants
Sex: Female, Male Female	29 Participants n=52 Participants	14 Participants n=29 Participants	43 Participants n=81 Participants
Sex: Female, Male Male	23 Participants n=52 Participants	15 Participants n=29 Participants	38 Participants n=81 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=52 Participants	1 Participants n=29 Participants	2 Participants n=81 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=52 Participants	28 Participants n=29 Participants	79 Participants n=81 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=29 Participants	0 Participants n=81 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=52 Participants	0 Participants n=29 Participants	0 Participants n=81 Participants
Race (NIH/OMB) Asian	14 Participants n=52 Participants	15 Participants n=29 Participants	29 Participants n=81 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=52 Participants	0 Participants n=29 Participants	0 Participants n=81 Participants
Race (NIH/OMB) Black or African American	3 Participants n=52 Participants	1 Participants n=29 Participants	4 Participants n=81 Participants
Race (NIH/OMB) White	35 Participants n=52 Participants	13 Participants n=29 Participants	48 Participants n=81 Participants
Race (NIH/OMB) More than one race	0 Participants n=52 Participants	0 Participants n=29 Participants	0 Participants n=81 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=52 Participants	0 Participants n=29 Participants	0 Participants n=81 Participants
Baseline Spleen Volume by Magnetic resonance imaging/computerized tomography (MRI/CT) in mL	—	835.21 mL n=26 Participants • Analysis population contained all MF participants who had baseline measurement.	835.21 mL n=26 Participants • Analysis population contained all MF participants who had baseline measurement.
Baseline Platelet Counts in thousands per microliter (10^3 cells/μL)	380.4 10^3 cells/μL STANDARD_DEVIATION 207.44 • n=52 Participants	190.5 10^3 cells/μL STANDARD_DEVIATION 209.64 • n=29 Participants	312.4 10^3 cells/μL STANDARD_DEVIATION 226.29 • n=81 Participants

PRIMARY outcome

Timeframe: Up to ~32 months

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

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who experienced an AE is presented.

Outcome measures

Measure	Essential Thrombocythemia (ET) n=52 Participants Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 Participants Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Percentage of Participants Who Experience an Adverse Event (AE)	98.1 Percentage of Participants	100.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~32 months

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

An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during participation in an investigational study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any clinically significant abnormalities in vital signs and lab values, untoward signs or symptoms experienced by the participant from the time of first dose with bomedemstat under this protocol until completion of the study. The percentage of participants who discontinued study intervention due to an AE is presented.

Outcome measures

Measure	Essential Thrombocythemia (ET) n=52 Participants Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 Participants Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Percentage of Participants Who Discontinue Study Intervention Due to an AE	15.4 Percentage of Participants	10.3 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline and Days 169, 339, 509, 679, 849 and 924

Population: The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Participants were analyzed according to treatment received in the study. Per protocol only participants with MF were analyzed for this outcome measure.

Mean Spleen volume reduction (mL) in participants with MF as measured by central laboratory imaging analysis of MRI (or CT where applicable) approximately every 48 weeks. Per protocol only participants with MF were analyzed for this outcome measure. The change in spleen volume from baseline is presented.

Outcome measures

Measure	Essential Thrombocythemia (ET) Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 Participants Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 679	—	-61.000 mL Standard Deviation 396.2520
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 169	—	-101.570 mL Standard Deviation 92.6876
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 339	—	-67.645 mL Standard Deviation 249.0079
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 509	—	-5.920 mL Standard Deviation 143.1692
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 849	—	-38.840 mL Standard Deviation NA Standard deviation is not estimable due to only 1 participant in the group.
Mean Spleen Volume Reduction Based on Spleen Volume Measured by MRI in Participants With MF. Day 924	—	80.575 mL Standard Deviation 10.3308

PRIMARY outcome

Timeframe: Baseline and Days 29, 57, 85, 113, 141, 169, 198, 226, 254, 282, 310, 338, 367, 395, 423, 451, 479, 507, 536, 564, 592, 620, and 648

Population: The modified intent to treat (mITT) population included all participants who were enrolled in the study, received at least 1 dose of study intervention, and who had a nonmissing baseline and at least 1 nonmissing postbaseline efficacy assessment. Per protocol only participants with ET were analyzed for this outcome measure. Participants were analyzed according to treatment received in the study.

Blood samples were taken at designated time points to determine platelet count. Percentage of participants with ET who achieve a reduction of platelet counts to <= 400 K/uL (400 x 10^9/L) in the absence of new thromboembolic events is presented.

Outcome measures

Measure	Essential Thrombocythemia (ET) n=52 Participants Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 29	77.1 Percentage of participants Interval 62.7 to 88.0	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 57	72.9 Percentage of participants Interval 58.2 to 84.7	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 85	72.0 Percentage of participants Interval 57.5 to 83.8	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 113	78.4 Percentage of participants Interval 64.7 to 88.7	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 141	91.8 Percentage of participants Interval 80.4 to 97.7	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 169	89.4 Percentage of participants Interval 76.9 to 96.5	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 198	86.7 Percentage of participants Interval 73.2 to 94.9	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 226	81.8 Percentage of participants Interval 67.3 to 91.8	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 254	79.5 Percentage of participants Interval 64.7 to 90.2	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 282	75.0 Percentage of participants Interval 59.7 to 86.8	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 310	81.4 Percentage of participants Interval 66.6 to 91.6	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 338	83.7 Percentage of participants Interval 69.3 to 93.2	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 367	76.2 Percentage of participants Interval 60.5 to 87.9	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 395	78.0 Percentage of participants Interval 62.4 to 89.4	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 423	80.0 Percentage of participants Interval 64.4 to 90.9	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 451	82.1 Percentage of participants Interval 66.5 to 92.5	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 479	75.7 Percentage of participants Interval 58.8 to 88.2	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 507	96.2 Percentage of participants Interval 80.4 to 99.9	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 536	94.7 Percentage of participants Interval 74.0 to 99.9	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 564	86.7 Percentage of participants Interval 59.5 to 98.3	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 592	72.7 Percentage of participants Interval 39.0 to 94.0	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 620	85.7 Percentage of participants Interval 42.1 to 99.6	—
Percentage of Participants With ET Who Achieve a Reduction of Platelet Counts to <= 400 K/uL (400 x 10^9/L) in the Absence of New Thromboembolic Events Day 648	83.3 Percentage of participants Interval 35.9 to 99.6	—

Adverse Events

Essential Thrombocythemia (ET)

Serious events: 19 serious events

Other events: 45 other events

Deaths: 2 deaths

Myelofibrosis (MF)

Serious events: 12 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Measure	Essential Thrombocythemia (ET) n=52 participants at risk Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 participants at risk Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Blood and lymphatic system disorders Blood loss anaemia	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Immune thrombocytopenia	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytosis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Cardiac disorders Supraventricular tachycardia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Cardiac disorders Wellens' syndrome	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gingival bleeding	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Haematemesis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Rectal haemorrhage	1.9% 1/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Cholecystitis acute	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Hypertransaminasaemia	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Hepatobiliary disorders Portal vein thrombosis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Abscess limb	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Appendicitis perforated	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Diverticulitis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Hepatitis B	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Influenza	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Parainfluenzae virus infection	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Pneumonia	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Sepsis	1.9% 1/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Fall	1.9% 1/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Fracture	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Rib fracture	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Skin laceration	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Wound	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Investigations Blood potassium increased	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Nervous system disorders Cerebral haemorrhage	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Acute kidney injury	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Haematuria	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Renal and urinary disorders Hydronephrosis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Vascular disorders Hypovolaemic shock	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.

Other adverse events

Measure	Essential Thrombocythemia (ET) n=52 participants at risk Participants with ET received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.	Myelofibrosis (MF) n=29 participants at risk Participants with MF received bomedemstat daily as an oral capsule. The daily dose of bomedemstat was titrated for each participant to a dose that reduced platelets to the target range associated with the participant's underlying MPN.
Blood and lymphatic system disorders Anaemia	19.2% 10/52 • Number of events 11 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	24.1% 7/29 • Number of events 16 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Increased tendency to bruise	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Neutropenia	7.7% 4/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	11.5% 6/52 • Number of events 13 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	41.4% 12/29 • Number of events 27 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytosis	5.8% 3/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Cardiac disorders Palpitations	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Ear and labyrinth disorders Vertigo	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Eye disorders Blepharitis	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal distension	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	7.7% 4/52 • Number of events 9 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Chronic gastritis	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Constipation	5.8% 3/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	9.6% 5/52 • Number of events 10 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	24.1% 7/29 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Epigastric discomfort	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Gingival bleeding	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	24.1% 7/29 • Number of events 14 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Haemorrhoids	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Mouth haemorrhage	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Mouth ulceration	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Nausea	11.5% 6/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	17.2% 5/29 • Number of events 10 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Gastrointestinal disorders Vomiting	9.6% 5/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Asthenia	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Fatigue	13.5% 7/52 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Non-cardiac chest pain	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Oedema peripheral	5.8% 3/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Peripheral swelling	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
General disorders Pyrexia	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Bronchitis	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations COVID-19	11.5% 6/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	37.9% 11/29 • Number of events 15 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Cellulitis	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Nasopharyngitis	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Oral herpes	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	7.7% 4/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Urinary tract infection	13.5% 7/52 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Infections and infestations Wound infection	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Contusion	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	20.7% 6/29 • Number of events 13 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Fall	9.6% 5/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Investigations Alanine aminotransferase increased	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Investigations Blood creatinine increased	5.8% 3/52 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Investigations SARS-CoV-2 test positive	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Investigations Urinary occult blood	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyperkalaemia	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Metabolism and nutrition disorders Iron deficiency	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	28.8% 15/52 • Number of events 24 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	48.3% 14/29 • Number of events 21 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthritis	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	9.6% 5/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	20.7% 6/29 • Number of events 7 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Joint swelling	3.8% 2/52 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 3/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.8% 3/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Nervous system disorders Dizziness	15.4% 8/52 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Nervous system disorders Dysgeusia	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Nervous system disorders Headache	13.5% 7/52 • Number of events 7 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.6% 5/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 4/52 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	9.6% 5/52 • Number of events 6 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	13.8% 4/29 • Number of events 7 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.8% 3/52 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	0.00% 0/29 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/52 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	15.4% 8/52 • Number of events 8 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 4 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Skin lesion	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Vascular disorders Haematoma	5.8% 3/52 • Number of events 5 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	10.3% 3/29 • Number of events 3 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Vascular disorders Hypertension	7.7% 4/52 • Number of events 7 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	3.4% 1/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.
Vascular disorders Hypotension	1.9% 1/52 • Number of events 1 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.	6.9% 2/29 • Number of events 2 • Death and adverse events up to ~32 months All-cause mortality was reported on all allocated participants. Serious and non-serious adverse events (AEs) were reported on all participants who received ≥1 dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@MSD.com

Results disclosure agreements

• Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
• Publication restrictions are in place

Restriction type: OTHER