Trial Outcomes & Findings for Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM (NCT NCT07150104)

Last Updated: 2026-06-25

Results Overview

Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2026-06-25

Participant Flow

This is a sub-study of the master study NCT04126200. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants from this sub study were enrolled in CE phase as CE Phase was not initiated due to business strategic reason.

The results presented are based on the data cut-off date of 17 Apr 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continuation of Treatment (PACT) phase and their safety data will be provided within a year of study completion.

Participant milestones

Participant milestones
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Overall Study STARTED	14
Overall Study Pharmacokinetic Population	14
Overall Study Safety Population	14
Overall Study DLT Evaluable Population	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Overall Study Withdrawal by Subject	2
Overall Study Ongoing at the time of analysis	5

Baseline Characteristics

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Nirogacestat, Pomalidomide, and Dexamethasone in Participants With RRMM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Age, Continuous	67.1 YEARS STANDARD_DEVIATION 11.92 • n=20 Participants
Sex: Female, Male Female	4 Participants n=20 Participants
Sex: Female, Male Male	10 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	2 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	2 Participants n=20 Participants
Race (NIH/OMB) White	10 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: DLT Evaluable Population included participants in DE Phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=11 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs)	2 Participants

PRIMARY outcome

Timeframe: Up to approximately 137 weeks

Population: Safety population included all participants who received at least one dose of any component of the combination therapy.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Adverse Events (AEs)	14 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to 137 weeks

Population: Safety population

Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to Grade 2	4 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to Grade 3	1 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Anemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin increased, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin increased, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin increased, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hemoglobin increased, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grade 2	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grade 3	5 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count decreased, Increase to Grade 4	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count increased, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count increased, Increase to Grade 2	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count increased, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Lymphocyte count increased, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil count decreased, Increase to Grade 1	1 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil count decreased, Increase to Grade 2	5 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil count decreased, Increase to Grade 3	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Neutrophil count decreased, Increase to Grade 4	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet count decreased, Increase to Grade 1	4 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet count decreased, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet count decreased, Increase to Grade 3	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Platelet count decreased, Increase to Grade 4	3 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline Leukocytosis, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White blood cell decreased, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White blood cell decreased, Increase to Grade 2	3 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White blood cell decreased, Increase to Grade 3	2 Participants
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline White blood cell decreased, Increase to Grade 4	0 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to 137 weeks

Population: Safety population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.

Blood samples were collected for the analysis of chemistry parameters. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. CPK = creatine kinase.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grade 2	3 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to Grade 1	4 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoglycemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to Grade 1	4 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to Grade 2	4 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypoalbuminemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK increased, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK increased, Increase to Grade 2	3 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK increased, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline CPK increased, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to Grade 2	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hyperkalemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grade 1	10 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Blood lactate dehydrogenase increased, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypermagnesemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to Grade 1	4 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypomagnesemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to Grade 2	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypernatremia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to Grade 1	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to Grade 2	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to Grade 3	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypercalcemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to Grade 1	2 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to Grade 2	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to Grade 3	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Hypocalcemia, Increase to Grade 4	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grade 1	0 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grade 3	1 Participants
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline Chronic Kidney Disease, Increase to Grade 4	1 Participants

PRIMARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Overall Response Rate (ORR)	57 Percentage of Participants Interval 28.9 to 82.3

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is defined as \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population.

Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Stringent Complete Response (sCR)	21 Percentage of Participants
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Complete Response (CR)	7 Percentage of Participants
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Very Good Partial Response (VGPR)	0 Percentage of Participants
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) Partial Response (PR)	29 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks)

Population: Pharmacokinetic (PK) population included all participants in the safety population from whom at least one PK sample has been obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC).

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 12 DAY 1, PRE-DOSE	936.5 Nanogram/ millilitre (ng/mL) Interval 0.0 to 1570.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 12 DAY 1, END OF INFUSION	14550.0 Nanogram/ millilitre (ng/mL) Interval 7810.0 to 21300.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 1, PRE-DOSE	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 18 DAY 1, PRE-DOSE	1270.0 Nanogram/ millilitre (ng/mL) Interval 1060.0 to 1790.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) END OF TREATMENT (~137 weeks)	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 1, END OF INFUSION	12450.0 Nanogram/ millilitre (ng/mL) Interval 3550.0 to 19400.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 1, 2 HOURS	11250.0 Nanogram/ millilitre (ng/mL) Interval 6960.0 to 15900.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 4, ANYTIME SAMPLE	3220.0 Nanogram/ millilitre (ng/mL) Interval 985.0 to 6620.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 8, ANYTIME SAMPLE	1410.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 2780.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 1 DAY 29, ANYTIME SAMPLE	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 2 DAY 1, PRE-DOSE	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 609.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 2 DAY 1, END OF INFUSION	11450.0 Nanogram/ millilitre (ng/mL) Interval 6610.0 to 18700.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 4 DAY 1, PRE-DOSE	666.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 13000.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 4 DAY 1, END OF INFUSION	15100.0 Nanogram/ millilitre (ng/mL) Interval 529.0 to 29100.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 6 DAY 1, PRE-DOSE	791.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 1280.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 6 DAY 1, END OF INFUSION	15000.0 Nanogram/ millilitre (ng/mL) Interval 7250.0 to 25100.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 9 DAY 1, PRE-DOSE	1021.5 Nanogram/ millilitre (ng/mL) Interval 0.0 to 2330.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) CYCLE 9 DAY 1, END OF INFUSION	12100.0 Nanogram/ millilitre (ng/mL) Interval 7060.0 to 34700.0

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: PK population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.

Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 2 DAY 1, END OF INFUSION	9510.0 Nanogram/ millilitre (ng/mL) Interval 4640.0 to 23200.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 4 DAY 1, PRE-DOSE	1830.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 13400.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 4 DAY 1, END OF INFUSION	14000.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 21100.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 6 DAY 1, PRE-DOSE	2710.0 Nanogram/ millilitre (ng/mL) Interval 1040.0 to 4640.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 6 DAY 1, END OF INFUSION	11900.0 Nanogram/ millilitre (ng/mL) Interval 7170.0 to 16900.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 9 DAY 1, PRE-DOSE	3020.0 Nanogram/ millilitre (ng/mL) Interval 977.0 to 5850.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 9 DAY 1, END OF INFUSION	12400.0 Nanogram/ millilitre (ng/mL) Interval 8620.0 to 15900.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 12 DAY 1, PRE-DOSE	2905.0 Nanogram/ millilitre (ng/mL) Interval 2000.0 to 5240.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 12 DAY 1, END OF INFUSION	12600.0 Nanogram/ millilitre (ng/mL) Interval 9000.0 to 18200.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 18 DAY 1, PRE-DOSE	3600.0 Nanogram/ millilitre (ng/mL) Interval 3300.0 to 4550.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody END OF TREATMENT (~137 weeks)	677.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 762.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 2 DAY 1, PRE-DOSE	353.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 18700.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 1, PRE-DOSE	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 21600.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 1, END OF INFUSION	10500.0 Nanogram/ millilitre (ng/mL) Interval 5010.0 to 34000.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 1, 2 HOURS	10350.0 Nanogram/ millilitre (ng/mL) Interval 7220.0 to 37400.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 4, ANYTIME SAMPLE	4200.0 Nanogram/ millilitre (ng/mL) Interval 1710.0 to 14100.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 8, ANYTIME SAMPLE	2230.0 Nanogram/ millilitre (ng/mL) Interval 511.0 to 14500.0
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody CYCLE 1 DAY 29, ANYTIME SAMPLE	0.0 Nanogram/ millilitre (ng/mL) Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for PK analysis of Belantamab mafodotin plasma total antibody.

Outcome measures

Outcome data not reported

SECONDARY outcome

Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 1, END OF INFUSION	71.55 Picogram / millilitre (pg/mL) Interval 0.0 to 181.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 1, 2 HOURS	104.50 Picogram / millilitre (pg/mL) Interval 0.0 to 210.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 4, ANYTIME SAMPLE	106.00 Picogram / millilitre (pg/mL) Interval 0.0 to 188.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 8, ANYTIME SAMPLE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 92.2
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 1 DAY 29, ANYTIME SAMPLE	0.00 Picogram / millilitre (pg/mL) Full range is not applicable as only a single participant was analyzed.
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 2 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 2 DAY 1, END OF INFUSION	57.80 Picogram / millilitre (pg/mL) Interval 0.0 to 197.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 4 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 97.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 4 DAY 1, END OF INFUSION	86.30 Picogram / millilitre (pg/mL) Interval 0.0 to 329.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 6 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 6 DAY 1, END OF INFUSION	68.60 Picogram / millilitre (pg/mL) Interval 0.0 to 303.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 9 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 9 DAY 1, END OF INFUSION	58.40 Picogram / millilitre (pg/mL) Interval 0.0 to 566.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 12 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 12 DAY 1, END OF INFUSION	28.40 Picogram / millilitre (pg/mL) Interval 0.0 to 71.8
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) CYCLE 18 DAY 1, PRE-DOSE	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0
DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) END OF TREATMENT (~137 weeks)	0.00 Picogram / millilitre (pg/mL) Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 1 Day -2; Predose on Cycle 1 Day 1, 4, 8; Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 2 Day 1

Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 2 DAY 1, PRE-DOSE	106.00 ng/mL Interval 0.0 to 751.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 2 DAY 1, 30 MINUTES	415.50 ng/mL Interval 0.0 to 1010.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 2 DAY 1, 1 HOUR	429.00 ng/mL Interval 0.8 to 1150.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 2 DAY 1, 2 HOURS	433.50 ng/mL Interval 18.3 to 864.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 2 DAY 1, 4 HOURS	217.50 ng/mL Interval 91.1 to 425.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY -2, PRE-DOSE	0.00 ng/mL Interval 0.0 to 0.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY -2, 30 MINUTES	449.00 ng/mL Interval 0.0 to 771.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY -2, 1 HOUR	453.00 ng/mL Interval 0.0 to 912.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY -2, 2 HOURS	294.00 ng/mL Interval 7.2 to 582.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY -2, 4 HOURS	147.50 ng/mL Interval 88.6 to 271.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY 1, PRE-DOSE	93.20 ng/mL Interval 20.5 to 885.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY 4, PRE-DOSE	110.50 ng/mL Interval 64.6 to 441.0
DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin CYCLE 1 DAY 8, PRE-DOSE	133.00 ng/mL Interval 31.3 to 306.0

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population

Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin	1 Participants

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be tested in screening assay, and positive samples were to be further characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.

Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=1 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Titer of ADAs Against Belantamab Mafodotin	100 Titer Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual titer value for this single participant.

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)	14 Participants

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: Safety population

The corneal events were graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results are presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.

Outcome measures

Outcome measures
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 Participants Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 1	7 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 2	1 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 3	0 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 4	0 Participants
DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade Grade 5	0 Participants

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

The corneal events were to be graded according to CTCAE version 5. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant. Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Results were to be presented for number of participants with any corneal events by maximum grade as per CTCAE grade version (v) 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

PFS is defined as the time from randomization until the earliest date of confirmed progressive disease (PD) per IMWG, or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

DoR is defined as the time from first documented evidence or PR or better until progressive disease per IMWG or death due to progressive disease among participants who achieve confirmed partial response or better.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (confirmed PR or better).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

OS is defined as the time from randomization until death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Number of participants with dose reduction or delay were to be evaluated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3: severe or medically significant; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 137 weeks

Population: No participants were enrolled as CE Phase was not initiated due to business strategic reason.

Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5.0. G1: mild; G2: moderate; G3: severe or medically significant; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

Outcome measures

Outcome data not reported

Adverse Events

0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone

Serious events: 12 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 participants at risk Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Blood and lymphatic system disorders Anaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Blood and lymphatic system disorders Febrile neutropenia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Cardiac disorders Atrial fibrillation	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Cardiac disorders Myocardial infarction	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Diarrhoea	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Hepatobiliary disorders Liver injury	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Atypical pneumonia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Device related infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Enterocolitis infectious	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Folliculitis	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Gastroenteritis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Pneumonia	42.9% 6/14 • Number of events 7 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Pneumonia influenzal	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Pulmonary sepsis	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Skin infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Subcutaneous abscess	7.1% 1/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Vascular device infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Injury, poisoning and procedural complications Infusion related reaction	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Acid-base balance disorder mixed	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Dehydration	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypokalaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Renal and urinary disorders Acute kidney injury	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.

Other adverse events

Other adverse events
Measure	0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Pomalidomide + Dexamethasone n=14 participants at risk Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 0.5 mg/kg belantamab mafodotin intravenous (IV) infusion as powder for solution once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 100 mg Nirogacestat administered orally twice a day (BID) up to Day 28. Along with 4 mg Pomalidomide orally per day (QD) on Days 1-21 of each 28-day cycle and Dexamethasone 40mg (20 mg for participants \>75 years old or BMI \<18.5 kg/m\^2) administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
Blood and lymphatic system disorders Anaemia	42.9% 6/14 • Number of events 10 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Blood and lymphatic system disorders Leukopenia	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Blood and lymphatic system disorders Neutropenia	42.9% 6/14 • Number of events 20 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Blood and lymphatic system disorders Thrombocytopenia	35.7% 5/14 • Number of events 7 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Cataract	14.3% 2/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Conjunctival hyperaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Corneal neovascularisation	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Dry eye	35.7% 5/14 • Number of events 8 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Ectropion	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Epiretinal membrane	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Eye allergy	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Eye irritation	21.4% 3/14 • Number of events 8 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Eye pain	28.6% 4/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Foreign body sensation in eyes	28.6% 4/14 • Number of events 9 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Keratitis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Macular degeneration	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Macular telangiectasia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Photophobia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Vision blurred	35.7% 5/14 • Number of events 10 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Visual acuity reduced	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Eye disorders Vitreous floaters	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Abdominal pain upper	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Constipation	28.6% 4/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Diarrhoea	64.3% 9/14 • Number of events 13 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Dyspepsia	14.3% 2/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Faeces pale	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Gastrooesophageal reflux disease	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Nausea	14.3% 2/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Tooth loss	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Asthenia	21.4% 3/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Axillary pain	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Fatigue	28.6% 4/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Oedema peripheral	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Peripheral swelling	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
General disorders Pyrexia	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Hepatobiliary disorders Hyperbilirubinaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Bronchitis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations COVID-19	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Chest wall abscess	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Conjunctivitis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Eye infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Folliculitis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Herpes zoster	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Influenza	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Nasopharyngitis	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Oral candidiasis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Pneumonia	28.6% 4/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Respiratory syncytial virus infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Respiratory tract infection	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Subcutaneous abscess	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Infections and infestations Upper respiratory tract infection	28.6% 4/14 • Number of events 11 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Injury, poisoning and procedural complications Fall	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Injury, poisoning and procedural complications Rib fracture	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Injury, poisoning and procedural complications Skin abrasion	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Injury, poisoning and procedural complications Skin laceration	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Alanine aminotransferase increased	14.3% 2/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Amylase increased	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Aspartate aminotransferase increased	7.1% 1/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Aspergillus test positive	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Blood chloride increased	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Blood creatinine increased	21.4% 3/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Blood lactate dehydrogenase increased	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Blood phosphorus increased	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Herpes simplex test positive	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Lymphocyte count decreased	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Neutrophil count decreased	7.1% 1/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Platelet count decreased	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Venous pressure jugular increased	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Investigations Weight decreased	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Dyslipidaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Folate deficiency	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hyperkalaemia	14.3% 2/14 • Number of events 3 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hyperlipidaemia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypoalbuminaemia	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypocalcaemia	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypokalaemia	28.6% 4/14 • Number of events 10 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypomagnesaemia	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hyponatraemia	14.3% 2/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Hypophosphataemia	42.9% 6/14 • Number of events 13 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Metabolism and nutrition disorders Iron deficiency	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Arthralgia	21.4% 3/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Back pain	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Bursitis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Costochondritis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Joint stiffness	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Joint swelling	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Muscle spasms	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Osteoarthritis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Brain fog	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Dementia Alzheimer's type	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Headache	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Neuropathy peripheral	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Peripheral motor neuropathy	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Nervous system disorders Syncope	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Psychiatric disorders Depression	14.3% 2/14 • Number of events 2 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Psychiatric disorders Insomnia	21.4% 3/14 • Number of events 4 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Psychiatric disorders Mood swings	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Renal and urinary disorders Haemoglobinuria	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Renal and urinary disorders Pollakiuria	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Renal and urinary disorders Renal impairment	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Renal and urinary disorders Urinary hesitation	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Respiratory, thoracic and mediastinal disorders Cough	28.6% 4/14 • Number of events 5 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Respiratory, thoracic and mediastinal disorders Dry throat	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Drug eruption	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Dry skin	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Hyperhidrosis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Precancerous skin lesion	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Rash	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Rash macular	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Rash papular	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Skin and subcutaneous tissue disorders Skin induration	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Vascular disorders Haematoma	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Vascular disorders Hypertension	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Vascular disorders Hypotension	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.
Vascular disorders Superficial vein thrombosis	7.1% 1/14 • Number of events 1 • All cause mortality, Non- Serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs) were collected upto approximately 137 weeks. Safety population included all participants who received at least one dose of any component of the combination therapy. The results presented are based on data cut-off date 17 Apr 2025. Safety data collection is still ongoing and will be provided within a year of study completion.

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