Trial Outcomes & Findings for Asciminib Treatment Optimization in ≥ 3rd Line CML-CP (NCT NCT04948333)

NCT ID: NCT04948333

Last Updated: 2025-12-23

Results Overview

Major Molecular Response (MMR) is defined as a significant reduction in the level of BCR::ABL1 transcripts, which are the genetic markers of chronic myeloid leukemia (CML). Specifically, MMR is achieved when there is a ≥ 3.0 log reduction in BCR::ABL1 transcripts compared to a standardized baseline, which corresponds to a BCR::ABL1/ABL1 ratio of ≤ 0.1% on the international scale (IS). The Major Molecular Response (MMR) rate at Week 48 for all patients with no evidence of MMR at baseline refers to the percentage of patients who achieve MMR after 48 weeks of treatment, despite not having MMR at the start.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 199 participants
• Primary outcome timeframe: Week 48
• Results posted on: 2025-12-23

Participant Flow

The study is conducted globally across 16 countries.

Participant milestones

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline Asciminib 40 mg b.i.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects With MMR at Baseline Asciminib 80 mg q.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Overall Study STARTED	85	84	14	16
Overall Study Full Analysis Set (FAS)	85	84	0	0
Overall Study Full Analysis Set 2 (FAS 2)	0	0	14	16
Overall Study Safety Set (SAF)	84	84	0	0
Overall Study Safety Set 2 (SAF 2)	0	0	14	16
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	85	84	14	16

Reasons for withdrawal

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline Asciminib 40 mg b.i.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects With MMR at Baseline Asciminib 80 mg q.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Overall Study Adverse Event	6	4	0	2
Overall Study Unsatisfactory Therapeutic Effect	4	3	0	0
Overall Study Progressive Disease	1	5	0	0
Overall Study Physician Decision	2	2	0	0
Overall Study Failure To Meet Continuation Criteria	2	1	0	0
Overall Study Withdrawal by Subject	2	0	0	1
Overall Study Protocol Violation	0	1	0	0
Overall Study Treatment ongoing at the time of the data cut-off date 12-Mar-2024	68	68	14	13

Baseline Characteristics

Asciminib Treatment Optimization in ≥ 3rd Line CML-CP

Baseline characteristics by cohort

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=85 Participants Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 Participants Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline n=14 Participants Asciminib 40 mg b.i.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects With MMR at Baseline n=16 Participants Asciminib 80 mg q.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Total n=199 Participants Total of all reporting groups
Age, Customized 18 - < 65 years	64 Participants n=68 Participants	59 Participants n=4 Participants	9 Participants n=219 Participants	11 Participants n=219 Participants	143 Participants n=880 Participants
Age, Customized 65 - < 75 years	12 Participants n=68 Participants	19 Participants n=4 Participants	4 Participants n=219 Participants	3 Participants n=219 Participants	38 Participants n=880 Participants
Age, Customized >=75 years	9 Participants n=68 Participants	6 Participants n=4 Participants	1 Participants n=219 Participants	2 Participants n=219 Participants	18 Participants n=880 Participants
Sex: Female, Male Female	37 Participants n=68 Participants	27 Participants n=4 Participants	6 Participants n=219 Participants	6 Participants n=219 Participants	76 Participants n=880 Participants
Sex: Female, Male Male	48 Participants n=68 Participants	57 Participants n=4 Participants	8 Participants n=219 Participants	10 Participants n=219 Participants	123 Participants n=880 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants
Race (NIH/OMB) Asian	21 Participants n=68 Participants	21 Participants n=4 Participants	2 Participants n=219 Participants	2 Participants n=219 Participants	46 Participants n=880 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	0 Participants n=880 Participants
Race (NIH/OMB) Black or African American	4 Participants n=68 Participants	2 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	6 Participants n=880 Participants
Race (NIH/OMB) White	58 Participants n=68 Participants	60 Participants n=4 Participants	12 Participants n=219 Participants	14 Participants n=219 Participants	144 Participants n=880 Participants
Race (NIH/OMB) More than one race	1 Participants n=68 Participants	0 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	1 Participants n=880 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=68 Participants	1 Participants n=4 Participants	0 Participants n=219 Participants	0 Participants n=219 Participants	2 Participants n=880 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Full Analysis Set (FAS)

Major Molecular Response (MMR) is defined as a significant reduction in the level of BCR::ABL1 transcripts, which are the genetic markers of chronic myeloid leukemia (CML). Specifically, MMR is achieved when there is a ≥ 3.0 log reduction in BCR::ABL1 transcripts compared to a standardized baseline, which corresponds to a BCR::ABL1/ABL1 ratio of ≤ 0.1% on the international scale (IS).

The Major Molecular Response (MMR) rate at Week 48 for all patients with no evidence of MMR at baseline refers to the percentage of patients who achieve MMR after 48 weeks of treatment, despite not having MMR at the start.

Outcome measures

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=85 Participants Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 Participants Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Major Molecular Response (MMR) Rate at Week 48 for All Patients With no Evidence of MMR at Baseline	42.35 Percentage of responders Interval 31.7 to 53.55	34.52 Percentage of responders Interval 24.48 to 45.69

SECONDARY outcome

Timeframe: Week 12, 24, 36, 72, 96 and 144

The Major Molecular Response (MMR) rate at alternative time points (weeks 12, 24, 36, 72, 96 and 144) for all patients with no evidence of MMR at baseline refers to the percentage of patients who achieve MMR after those respective weeks of treatment, despite not having MMR at the start. MMR itself is defined as achieving a BCR::ABL1 ratio of ≤ 0.1%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48.

Population: Full Analysis Set 2 (FAS 2) and with evaluable data at the pre-specified time points

The Major Molecular Response (MMR) rate at Week 48 for patients with MMR at baseline refers to the percentage of patients who maintain or achieve MMR after 48 weeks of treatment. MMR itself is defined as achieving a BCR::ABL1 ratio of ≤ 0.1%.

Outcome measures

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=14 Participants Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=14 Participants Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Major Molecular Response (MMR) Rate at Week 48 for Patients With MMR at Baseline	100 Percentage of responders Interval 76.84 to 100.0	87.5 Percentage of responders Interval 61.65 to 98.45

SECONDARY outcome

Timeframe: From the date of enrollment to the date of first documented MMR, assessed up to 144 weeks

Time to MMR defined as the time from the date of randomization to the date of the first documented MMR. MMR itself is defined as achieving a BCR::ABL1 ratio of ≤ 0.1%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12, 24, 36 and 48

Population: Full Analysis Set (FAS)

The rate of BCR::ABL1 ≤ 10% refers to the percentage of patients who achieve a BCR::ABL1 level of 10% or lower within the first 48 weeks of treatment.

Outcome measures

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=85 Participants Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 Participants Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline Week 12	69.4 Percentage of BCR::ABL1 <= 10% Interval 58.47 to 78.95	81.0 Percentage of BCR::ABL1 <= 10% Interval 70.92 to 88.7
Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline Week 24	72.9 Percentage of BCR::ABL1 <= 10% Interval 62.21 to 82.01	76.2 Percentage of BCR::ABL1 <= 10% Interval 65.65 to 84.81
Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline Week 36	71.8 Percentage of BCR::ABL1 <= 10% Interval 60.96 to 81.0	82.1 Percentage of BCR::ABL1 <= 10% Interval 72.26 to 89.65
Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline Week 48	71.8 Percentage of BCR::ABL1 <= 10% Interval 60.96 to 81.0	78.6 Percentage of BCR::ABL1 <= 10% Interval 68.26 to 86.78

SECONDARY outcome

Timeframe: Week 12, 24, 36 and 48.

Population: Full Analysis Set (FAS)

The rate of BCR::ABL1 ≤ 1% refers to the percentage of patients who achieve a BCR::ABL1 level of 1% or lower within the first 48 weeks of treatment.

Outcome measures

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=85 Participants Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 Participants Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Rate of BCR::ABL1 ≤ 1% for Subjects Without MMR at Baseline Week 36	63.5 Percentage of BCR::ABL1 ≤ 1% Interval 52.38 to 73.71	64.3 Percentage of BCR::ABL1 ≤ 1% Interval 53.08 to 74.45
Rate of BCR::ABL1 ≤ 1% for Subjects Without MMR at Baseline Week 48	64.7 Percentage of BCR::ABL1 ≤ 1% Interval 53.59 to 74.77	59.5 Percentage of BCR::ABL1 ≤ 1% Interval 48.25 to 70.1
Rate of BCR::ABL1 ≤ 1% for Subjects Without MMR at Baseline Week 12	61.2 Percentage of BCR::ABL1 ≤ 1% Interval 49.99 to 71.56	53.6 Percentage of BCR::ABL1 ≤ 1% Interval 42.35 to 64.53
Rate of BCR::ABL1 ≤ 1% for Subjects Without MMR at Baseline Week 24	64.7 Percentage of BCR::ABL1 ≤ 1% Interval 53.59 to 74.77	58.3 Percentage of BCR::ABL1 ≤ 1% Interval 47.06 to 69.0

SECONDARY outcome

Timeframe: Week 12, 24, 36, 48, 72, 96 and 144.

Deep molecular responses (MR4) is defined as a ≥ 4 log reduction in BCR::ABL1 transcripts compared to the standardized baseline, equivalent to 0.01% BCR::ABL1/ABL1 by the international scale (IS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12, 24, 36, 48, 72, 96 and 144.

Deep molecular responses (MR4.5) is defined as a ≥ 4.5 log reduction in BCR::ABL1 transcripts compared to the standardized baseline, equivalent to 0.0032% BCR::ABL1/ABL1 by the international scale (IS).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 and end of treatment (up to 144 weeks)

Cytogenetic Response is assessed based on the percentage of Philadelphia chromosome-positive (Ph+) metaphases in the bone marrow, with a review of at least 20 metaphases required.

Complete Cytogenetic Response (CCyR) is defined as 0% Ph+ metaphases in the bone marrow.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 144 weeks

High-risk additional chromosomal abnormalities (ACAs) are specific chromosomal abnormalities that are considered to increase the risk in Philadelphia chromosome-positive (Ph+) cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to end of treatment up to 144 weeks.

The cumulative molecular response rate refers to the proportion of subjects achieving a BCR::ABL1 level of ≤ 10% on the international scale (IS) over a specified period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to end of treatment up to 144 weeks.

The cumulative molecular response rate refers to the proportion of subjects achieving a BCR::ABL1 level of ≤ 1% on the international scale (IS) over a specified period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to end of treatment up to 144 weeks.

The cumulative molecular response rate refers to the proportion of subjects achieving MMR, defined as a BCR::ABL1 ratio of ≤ 0.1% on the international scale (IS), over a specified period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to end of treatment up to 144 weeks.

The cumulative molecular response rate refers to the proportion of subjects achieving MR4, defined as a ≥ 4 log reduction in BCR::ABL1 transcripts compared to the standardized baseline, equivalent to 0.01% BCR::ABL1/ABL1 by the international scale (IS), over a specified period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From enrollment to end of treatment up to 144 weeks.

The cumulative molecular response rate refers to the proportion of subjects achieving MR4.5, defined as a ≥ 4.5 log reduction in BCR::ABL1 transcripts compared to the standardized baseline, equivalent to 0.0032% BCR::ABL1/ABL1 by the international scale (IS), over a specified period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of the first documented molecular response at MMR level to the date of first documented loss of the response level or death due to any cause, whichever occurs first, assessed up to 144 weeks.

Duration of MMR is defined as the time from the date of first documented MMR to the earliest date of loss of MMR, progression to accelerated phase (AP) or blast crisis (BC), or CML-related death. The duration of MMR is analyzed for the subjects in FAS who achieved MMR at any time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first documented MR4 without loss of MMR to the date of first documented loss of the response level or death due to any cause, whichever occurs first, assessed up to 144 weeks.

Duration of MR4 without loss of MMR refers to the period during which a patient maintains a deep molecular response (MR4) without experiencing a loss of Major Molecular Response (MMR).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 144 weeks.

Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause, assessed up to approximately 144 weeks. The time will be censored at the date of last study assessment (PCR, cytogenetic, hematologic or extramedullary) or last post-treatment follow-up for subjects without event. PFS (in months) is calculated as: (date of disease progression/death or censoring date - date of randomization +1)/30.4375.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 144 weeks.

Overall Survival (OS) is defined as the time from treatment assignment to death due to any cause during study, assessed up to 144 weeks. Subjects who are alive at the time of the analysis data cutoff date will be censored at the date of last contact before the cut-off date. OS (in months) is calculated as: (date of death or censoring date - date of randomization + 1)/30.4375.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 144 weeks.

Time from treatment assignment to treatment failure is defined as BCR-ABL1>10%, assessed up to 144 weeks. For subjects who have not reached treatment failure, their TTFs will be censored at the time of last study assessment (PCR, cytogenetic, hematologic or extramedullary) before the cut-off date. TTF (in months) is calculated as: (date of treatment failure or censoring date - date of randomization + 1)/30.4375.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).

The MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) is a 26 item self-administered questionnaire for adult CML patients. Twenty of the items measure the severity of disease-related symptoms (symptom burden) and are scored from 0 (not present) to 10 (as bad as you can imagine) and 6 items that measure symptom interference with daily life (interference) scored from 0 (did not interfere) to 10 (interfered completely). For symptom burden, total scores range from 0 to 200 and for interference range from 0 to 60, with higher scores indicates high impact on severity of chronic myeloid leukemia-related symptoms and on impact of these symptoms on daily functioning for the patient.

Outcome measures

Outcome data not reported

Adverse Events

Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline

Serious events: 9 serious events

Other events: 67 other events

Deaths: 0 deaths

Asciminib 80 mg q.d. - Subjects Without MMR at Baseline

Serious events: 9 serious events

Other events: 67 other events

Deaths: 1 deaths

Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Asciminib 80 mg q.d. - Subjects With MMR at Baseline

Serious events: 5 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=84 participants at risk Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 participants at risk Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline n=14 participants at risk Asciminib 40 mg b.i.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects With MMR at Baseline n=16 participants at risk Asciminib 80 mg q.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Blood and lymphatic system disorders Anaemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Febrile neutropenia	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Lipase increased	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Hypersplenism	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Neutropenia	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Acute coronary syndrome	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Angina pectoris	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Atrial fibrillation	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Cardiac failure	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Coronary artery disease	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Supraventricular tachycardia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Eye disorders Blindness unilateral	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Appendicitis	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Dengue fever	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Influenza	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Streptococcal bacteraemia	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Injury, poisoning and procedural complications Fall	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Platelet count decreased	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Cerebrovascular accident	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Cervicobrachial syndrome	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Epilepsy	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Transient ischaemic attack	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Renal and urinary disorders Renal failure	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Reproductive system and breast disorders Pelvic haematoma	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).

Other adverse events

Measure	Asciminib 40 mg b.i.d. - Subjects Without MMR at Baseline n=84 participants at risk Asciminib 40 mg b.i.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects Without MMR at Baseline n=84 participants at risk Asciminib 80 mg q.d. - Subjects without MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 40 mg b.i.d. - Subjects With MMR at Baseline n=14 participants at risk Asciminib 40 mg b.i.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (40 mg BID). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.	Asciminib 80 mg q.d. - Subjects With MMR at Baseline n=16 participants at risk Asciminib 80 mg q.d. - Subjects with MMR at baseline: Participants will be treated with 80 mg of ABL001 (80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Papule	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Pruritus	14.3% 12/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	21.4% 3/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	31.2% 5/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Rash	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Rash maculo-papular	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Vascular disorders Angiopathy	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Vascular disorders Flushing	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Vascular disorders Hot flush	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Vascular disorders Hypertension	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Anaemia	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Leukopenia	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Neutropenia	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Blood and lymphatic system disorders Thrombocytopenia	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	10.7% 9/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Angina pectoris	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Atrial fibrillation	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Bundle branch block left	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Cardiac disorders Cardiac failure	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Ear and labyrinth disorders Vertigo	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Ear and labyrinth disorders Vertigo positional	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Endocrine disorders Cushingoid	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Eye disorders Dry eye	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Abdominal discomfort	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Abdominal pain	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Abdominal pain upper	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Constipation	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Diarrhoea	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	25.0% 4/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Dry mouth	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Dyspepsia	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Flatulence	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Macule	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Dry skin	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Gastritis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Gastrooesophageal reflux disease	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Haemorrhoids	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Lip disorder	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Nausea	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	9.5% 8/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	18.8% 3/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Gastrointestinal disorders Proctalgia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Asthenia	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Fatigue	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 12/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Gait disturbance	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Influenza like illness	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Oedema peripheral	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Pain	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
General disorders Pyrexia	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Bacteraemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Bronchitis	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	18.8% 3/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations COVID-19	13.1% 11/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	10.7% 9/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	21.4% 3/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	18.8% 3/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Folliculitis	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Gastroenteritis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Influenza	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Lower respiratory tract infection	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Nasopharyngitis	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Oral herpes	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Pharyngitis	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Pneumonia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Respiratory tract infection	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Sinusitis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Tracheobronchitis viral	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Upper respiratory tract infection	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Urinary tract infection	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Infections and infestations Viral infection	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Alanine aminotransferase increased	10.7% 9/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Amylase increased	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Aspartate aminotransferase increased	9.5% 8/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Blood alkaline phosphatase increased	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Blood cholesterol increased	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Blood creatine phosphokinase increased	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Blood glucose increased	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Electrocardiogram QT prolonged	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Gamma-glutamyltransferase increased	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Glycosylated haemoglobin increased	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations High density lipoprotein decreased	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Lipase increased	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Low density lipoprotein increased	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Platelet count decreased	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 6/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Prothrombin time prolonged	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Weight decreased	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Investigations Weight increased	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Hypertriglyceridaemia	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Arthralgia	11.9% 10/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	15.5% 13/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	21.4% 3/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	25.0% 4/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Back pain	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	8.3% 7/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Gouty tophus	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Muscle spasms	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Myalgia	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	25.0% 4/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Dizziness	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Headache	9.5% 8/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	9.5% 8/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	25.0% 4/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Hypoaesthesia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Nervous system disorders Memory impairment	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Psychiatric disorders Insomnia	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Psychiatric disorders Suicidal ideation	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Renal and urinary disorders Micturition disorder	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Reproductive system and breast disorders Penile erythema	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Cough	2.4% 2/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.0% 5/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 4/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	3.6% 3/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	14.3% 2/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	12.5% 2/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	7.1% 1/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).
Skin and subcutaneous tissue disorders Acne	0.00% 0/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	1.2% 1/84 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	0.00% 0/14 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).	6.2% 1/16 • From first dose of study treatment up to the cut-off date for the Week 48 primary analysis (12-Mar-2024), approximately 29 months. All-cause Mortality was assessed for all participants enrolled in the study, while Serious and Other Adverse Events were assessed for all participants who received at least one dose of the study medication (Safety Set (SAF) for subjects without MMR at baseline and Safety Set 2 (SAF2) for subjects with MMR at baseline).

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER