Trial Outcomes & Findings for An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments (NCT NCT03828292)
NCT ID: NCT03828292
Last Updated: 2025-08-19
Results Overview
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, MCHC, MCH, MCV, erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes, and increases to high from baseline values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
Baseline (Day 1) and up to approximately 212 weeks
Results posted on
2025-08-19
Participant Flow
The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants benefiting from drug continued to receive study drug until discontinuation or withdrawal from study.
Participant milestones
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
|---|---|---|---|---|---|---|
|
Main Study: Part 1 (Up to 141 Weeks)
STARTED
|
4
|
4
|
0
|
0
|
0
|
0
|
|
Main Study: Part 1 (Up to 141 Weeks)
COMPLETED
|
4
|
3
|
0
|
0
|
0
|
0
|
|
Main Study: Part 1 (Up to 141 Weeks)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
STARTED
|
0
|
0
|
3
|
4
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
NOT COMPLETED
|
0
|
0
|
3
|
4
|
0
|
0
|
|
PACT Phase (From 212 to 286 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
2
|
2
|
|
PACT Phase (From 212 to 286 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
2
|
2
|
|
PACT Phase (From 212 to 286 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
|---|---|---|---|---|---|---|
|
Main Study: Part 1 (Up to 141 Weeks)
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
Progressive disease
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Main Study: Part 2 (Up to 212 Weeks)
Transitioned to PACT
|
0
|
0
|
2
|
2
|
0
|
0
|
Baseline Characteristics
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments
Baseline characteristics by cohort
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
n=4 Participants
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
20 to 76 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Asian- Japanese Heritage
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: DLT Evaluable population included participants fulfilling the 'All Treated' population (all eligible participants who received at least 1 dose of study treatment) criteria, and those who received a complete infusion in 21- day Cycle 1.
DLT is an Adverse Event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment for abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 21Population: DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of bortezomib/dexamethasone in 21-day Cycle 1.
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm A: Number of Participants With DLTs
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to Day 28Population: DLT Evaluable population included participants fulfilling the 'All Treated' population criteria, and those who received a complete infusion of Belantamab Mafodotin and at least 75% of planned doses of pomalidomide/dexamethasone in 28-day Cycle 1.
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm B: Number of Participants With DLTs
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 141 weeksPopulation: All Treated Population included all eligible participants who received at least 1 dose of study treatment.
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. SAEs are subset of AEs.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 212 weeksPopulation: All Treated Population
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Only those participants with data available at specified category have been analyzed.
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Any Grade Increase
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Any Grade Increase
|
1 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Any Grade Increase
|
3 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Any Grade Increase
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Any Grade Increase
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Any Grade Increase
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 3
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Any Grade Increase
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Any Grade Increase
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Any Grade Increase
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 3
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Any Grade Increase
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Any Grade Increase
|
0 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Any Grade Increase
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Change to Normal or No Change
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Increase to High
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Decrease to Low
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Change to Normal or No Change
|
0 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Increase to High
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Change to Normal or No Change
|
4 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Increase to High
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Change to Normal or No Change
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Increase to High
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Decrease to Low
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Change to Normal or No Change
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Increase to High
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Decrease to Low
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Change to Normal or No Change
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Increase to High
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified category have been analyzed.
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to NCI-CTCAE v 4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Any Grade Increase
|
1 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypoglycemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Any Grade Increase
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Any Grade Increase
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Albumin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Any Grade Increase
|
2 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
ALP, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Any Grade Increase
|
3 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
AST, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Bilirubin, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypercalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Any Grade Increase
|
3 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypocalcemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
CK, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Creatinine, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Any Grade Increase
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
GGT, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypermagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Any Grade Increase
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypomagnesemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Any Grade Increase
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Phosphate, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperkalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Any Grade Increase
|
3 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 3
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypokalemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hypernatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyponatremia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
Hyperuricemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified category have been analyzed. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Change to Normal or No Change
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Change to Normal or No Change
|
3 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Direct Bilirubin, Increase to High
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Decrease to Low
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Change to Normal or No Change
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Chloride, Increase to High
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Change to Normal or No Change
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
C Reactive Protein, Increase to High
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Lactate Dehydrogenase, Increase to High
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Decrease to Low
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Change to Normal or No Change
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Protein, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Change to Normal or No Change
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
Urea, Increase to High
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Any Grade Increase
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Any Grade Increase
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 3
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Any Grade Increase
|
4 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 3
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 4
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Any Grade Increase
|
4 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 3
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Any Grade Increase
|
4 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 3
|
4 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 4
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Change to Normal or No Change
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Change to Normal or No Change
|
3 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Increase to High
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Decrease to Low
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Change to Normal or No Change
|
4 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Increase to High
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Decrease to Low
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Change to Normal or No Change
|
3 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Decrease to Low
|
1 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Change to Normal or No Change
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Increase to High
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Change to Normal or No Change
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Change to Normal or No Change
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Change to Normal or No Change
|
2 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Increase to High
|
2 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Decrease to Low
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Change to Normal or No Change
|
1 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Increase to High
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population.
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Any Grade Increase
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 3
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Anemia, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Hemoglobin increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Leukocytosis, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Any Grade Increase
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 3
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
White blood cell decreased, Increase to Grade 4
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Any Grade Increase
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 3
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count decreased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Any Grade Increase
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Lymphocyte count increased, Increase to Grade 4
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Any Grade Increase
|
1 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 3
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Neutrophils, Increase to Grade 4
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Any Grade Increase
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 3
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Platelets, Increase to Grade 4
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Participants are counted twice if the participant has values that changed "Decreased to Low" and "Increased to High", so the sum of the percentages may not add to 100% for each category.
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, MCHC, MCH, MCV, erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes, and increases to high from baseline values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Change to Normal or No Change
|
3 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Basophils, Increase to High
|
0 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Change to Normal or No Change
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Eosinophils, Increase to High
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Decrease to Low
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Change to Normal or No Change
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Hematocrit, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Decrease to Low
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Change to Normal or No Change
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCH, Increase to High
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Decrease to Low
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Change to Normal or No Change
|
3 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCHC, Increase to High
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Decrease to Low
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Change to Normal or No Change
|
0 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
MCV, Increase to High
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Decrease to Low
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Change to Normal or No Change
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Monocytes, Increase to High
|
2 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Decrease to Low
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Change to Normal or No Change
|
3 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Erythrocytes, Increase to High
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Decrease to Low
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Change to Normal or No Change
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Reticulocytes, Increase to High
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Only those participants with data available at specified category have been analyzed.
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, No Change/Decreased
|
4 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to SMALL
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to MODERATE
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to LARGE
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, No Change/Decreased
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to +-
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 1+
|
1 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 2+
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 3+
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Unknown
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified category have been analyzed.
Urine samples were collected to analyze presence of occult blood and protein in urine by dipstick method. Data for worst-case post baseline urinalysis results is presented. Result for urinalysis parameters were recorded as no change/decreased, Increase to SMALL, Increase to MODERATE, Increase to LARGE, and any increase including increase to +-, 1+, 2+, 3+, unknown indicating proportional concentrations in the urine sample.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, No Change/Decreased
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to SMALL
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to MODERATE
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Occult Blood, Increase to LARGE
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, No Change/Decreased
|
1 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to +-
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 1+
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 2+
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Increase to 3+
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein
Protein, Unknown
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH)
Baseline (Day 1)
|
7.13 pH
Standard Deviation 0.750
|
5.38 pH
Standard Deviation 0.479
|
|
Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH)
CFB to 141 Weeks
|
-0.75 pH
Standard Deviation 0.645
|
0.67 pH
Standard Deviation 1.155
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine pH levels. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Change From Baseline in Urine Potential of Hydrogen (pH)
Baseline (Day 1)
|
6.33 pH
Standard Deviation 1.041
|
5.25 pH
Standard Deviation 0.500
|
|
Part 2: Change From Baseline in Urine Potential of Hydrogen (pH)
CFB to 212 weeks
|
0.00 pH
|
1.50 pH
Standard Deviation 0.707
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Change From Baseline in Urine Specific Gravity by Dipstick
Baseline (Day 1)
|
1.0128 Ratio
Standard Deviation 0.00591
|
1.0190 Ratio
Standard Deviation 0.00408
|
|
Part 1: Change From Baseline in Urine Specific Gravity by Dipstick
CFB to 141 Weeks
|
-0.0010 Ratio
Standard Deviation 0.01010
|
-0.0037 Ratio
Standard Deviation 0.00451
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
Urine samples were collected to analyze urine specific gravity. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Change From Baseline in Urine Specific Gravity by Dipstick
CFB to 212 Weeks
|
-0.0070 Ratio
|
-0.0055 Ratio
Standard Deviation 0.00354
|
|
Part 2: Change From Baseline in Urine Specific Gravity by Dipstick
Baseline (Day 1)
|
1.0167 Ratio
Standard Deviation 0.00723
|
1.0218 Ratio
Standard Deviation 0.00608
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Any Grade Increase
|
3 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 2
|
2 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 3
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Any Grade Increase
|
2 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 2
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 3
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population.
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade (G) 0 (\<120 millimeter of mercury \[mmHg\]), G1 (120-139 mmHg), G2 (140-159 mmHg), G3 (\>=160 mmHg). For DBP: G0 (\<80 mmHg), G1 (80-89 mmHg), G2 (90-99 mmHg), G3 (\>=100 mmHg). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a maximum post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Any Grade Increase
|
2 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 2
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
SBP, Increase to Grade 3
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Any Grade Increase
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 2
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP, Increase to Grade 3
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Decrease to =<35
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Change to Normal or to No Change
|
4 Participants
|
4 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Increase to >=38
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population.
Temperature was measured after resting for at least 5 minutes. The abnormal ranges for body temperature were (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Decrease to <=35
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Change to Normal or No Change
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature
Increase to >=38
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Decrease to Low (<60 bpm)
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Change to Normal or No Change
|
3 Participants
|
3 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Increase to High (>100 bpm)
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population.
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Decrease to Low (<60 bpm)
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Change to Normal or No Change
|
0 Participants
|
3 Participants
|
|
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Increase to High (>100 bpm)
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Any Grade Increase
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Increase to Grade 2 (481 - 500 msec))
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)
Increase to Grade 3 (>= 501 msec))
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population. Only those participants with data available at specified time points have been analyzed.
12-lead electrocardiogram (ECG) was obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Grade 0 (\<450 millisecond (msec)), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (≥501 msec). Higher grade indicates greater severity. Data for participants with worst-case post baseline with any grade increase and a post-baseline grade increase to G2 and G3 from their baseline grade are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF
Any Grade Increase
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF
Increase to Grade 2 (481 - 500 msec)
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF
Increase to Grade 3 (>= 501 msec)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 141 weeksPopulation: All treated population.
The number of participants with worst-case post baseline performance status have been presented as 0-5. Where, 0- Fully active; 1- Restricted in strenuous activity but able to carry out light work activities; 2- Capable of self-care but unable to carry out any work activities; 3- Capable of limited self care, confined to bed/chair more than 50% of waking hours; 4- Completely disabled; can't carry on any self care; totally confined to bed/chair and 5- Dead.Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
0 Participants
|
1 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
3 Participants
|
2 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
3
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
4-5
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and up to approximately 212 weeksPopulation: All treated population.
Any change in ECOG Performance status that was clinically significant in the medical and scientific judgment of the investigator and not related to an underlying disease was reported.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic (PK) population included all participants in all treated population from whom at least one PK sample was obtained, analyzed, and was measurable. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
|
3694.5965 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 26.33
|
3807.9179 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 41.80
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
4177.9497 h*ug/mL
Geometric Coefficient of Variation 28.48
|
4243.1678 h*ug/mL
Geometric Coefficient of Variation 48.78
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
3606.0173 h*ug/mL
Geometric Coefficient of Variation 22.64
|
2392.2534 h*ug/mL
Geometric Coefficient of Variation 128.99
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
35.026301 milliliter per hour (mL/h)
Geometric Coefficient of Variation 37.38
|
45.340473 milliliter per hour (mL/h)
Geometric Coefficient of Variation 37.25
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
7.373 Day
Interval 6.92 to 8.38
|
7.779 Day
Interval 5.44 to 9.26
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
0.00385688 1/hour (h)
Geometric Coefficient of Variation 8.96
|
0.00394671 1/hour (h)
Geometric Coefficient of Variation 27.64
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
7.475899 Liter (L)
Geometric Coefficient of Variation 29.10
|
8.216505 Liter (L)
Geometric Coefficient of Variation 36.05
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
21.578 Day
Interval 15.14 to 22.12
|
21.079 Day
Interval 1.0 to 22.03
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
2.600 hour (h)
Interval 1.58 to 3.68
|
1.635 hour (h)
Interval 0.67 to 1.68
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
30.28 ug/mL
Geometric Coefficient of Variation 24.32
|
39.42 ug/mL
Geometric Coefficient of Variation 14.15
|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 2
|
32.52 ug/mL
Geometric Coefficient of Variation 14.13
|
31.44 ug/mL
Geometric Coefficient of Variation 58.71
|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 3
|
23.25 ug/mL
Geometric Coefficient of Variation 20.83
|
32.20 ug/mL
|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 6
|
23.60 ug/mL
|
29.22 ug/mL
Geometric Coefficient of Variation 24.69
|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 9
|
24.50 ug/mL
|
—
|
|
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 12
|
—
|
34.50 ug/mL
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
36.35 ug/mL
Geometric Coefficient of Variation 19.12
|
41.25 ug/mL
Geometric Coefficient of Variation 12.80
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 2
|
32.52 ug/mL
Geometric Coefficient of Variation 14.13
|
31.44 ug/mL
Geometric Coefficient of Variation 58.71
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 3
|
23.25 ug/mL
Geometric Coefficient of Variation 20.83
|
32.20 ug/mL
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 6
|
23.60 ug/mL
|
29.22 ug/mL
Geometric Coefficient of Variation 24.69
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 9
|
24.50 ug/mL
|
—
|
|
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 12
|
—
|
34.50 ug/mL
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
1.45 ug/mL
Geometric Coefficient of Variation 29.42
|
1.39 ug/mL
Geometric Coefficient of Variation 109.19
|
|
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 2
|
2.41 ug/mL
Geometric Coefficient of Variation 75.30
|
1.76 ug/mL
|
|
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 5
|
3.17 ug/mL
|
2.20 ug/mL
|
|
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 8
|
3.60 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
6358.4427 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 33.08
|
7143.7202 Hour*microgram/millilitre (h*ug/mL)
Geometric Coefficient of Variation 45.60
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
6939.1227 h*ug/mL
Geometric Coefficient of Variation 31.13
|
6789.2291 h*ug/mL
Geometric Coefficient of Variation 11.80
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
5839.2501 h*ug/mL
Geometric Coefficient of Variation 32.96
|
4046.1161 h*ug/mL
Geometric Coefficient of Variation 179.35
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
22.017014 mL/h
Geometric Coefficient of Variation 34.80
|
25.916718 mL/h
Geometric Coefficient of Variation 25.61
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
10.046 Day
Interval 6.92 to 10.57
|
9.512 Day
Interval 7.46 to 11.56
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
0.00319945 1/h
Geometric Coefficient of Variation 23.42
|
0.00310928 1/h
Geometric Coefficient of Variation 31.74
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
6.390107 Liter (L)
Geometric Coefficient of Variation 18.84
|
6.718238 Liter (L)
Geometric Coefficient of Variation 59.09
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
18.627 day
Interval 14.08 to 22.12
|
21.079 day
Interval 1.0 to 22.03
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
2.695 hour (h)
Interval 1.62 to 8.53
|
1.675 hour (h)
Interval 0.63 to 3.65
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
32.68 ug/mL
Geometric Coefficient of Variation 27.15
|
45.65 ug/mL
Geometric Coefficient of Variation 8.62
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 2
|
38.17 ug/mL
Geometric Coefficient of Variation 17.01
|
40.97 ug/mL
Geometric Coefficient of Variation 14.90
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 3
|
35.56 ug/mL
Geometric Coefficient of Variation 18.19
|
46.10 ug/mL
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 6
|
32.00 ug/mL
|
39.14 ug/mL
Geometric Coefficient of Variation 19.27
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 9
|
40.90 ug/mL
|
—
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 12
|
—
|
36.60 ug/mL
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
39.51 ug/mL
Geometric Coefficient of Variation 17.00
|
48.89 ug/mL
Geometric Coefficient of Variation 14.07
|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 2
|
38.17 ug/mL
Geometric Coefficient of Variation 17.01
|
40.97 ug/mL
Geometric Coefficient of Variation 14.90
|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 3
|
35.56 ug/mL
Geometric Coefficient of Variation 18.19
|
46.10 ug/mL
|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 6
|
32.00 ug/mL
|
39.14 ug/mL
Geometric Coefficient of Variation 19.27
|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 9
|
40.90 ug/mL
|
—
|
|
Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 12
|
—
|
36.60 ug/mL
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
4.47 ug/mL
Geometric Coefficient of Variation 22.16
|
5.19 ug/mL
Geometric Coefficient of Variation 104.06
|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 2
|
6.34 ug/mL
Geometric Coefficient of Variation 87.45
|
6.07 ug/mL
|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 5
|
11.40 ug/mL
|
4.04 ug/mL
Geometric Coefficient of Variation 152.78
|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 8
|
18.10 ug/mL
|
—
|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 11
|
—
|
1.37 ug/mL
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF)
|
73.3412 h*ug/mL
Geometric Coefficient of Variation 44.73
|
141.9031 h*ug/mL
Geometric Coefficient of Variation 77.03
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
748.94 ug/mL
Geometric Coefficient of Variation 30.49
|
2797.27 ug/mL
Geometric Coefficient of Variation 326.50
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
6.940 day
Interval 6.84 to 14.89
|
6.930 day
Interval 1.0 to 7.02
|
SECONDARY outcome
Timeframe: Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
16.380 hour (h)
Interval 8.55 to 24.58
|
16.240 hour (h)
Interval 8.45 to 24.1
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 1
|
304.99 ug/mL
Geometric Coefficient of Variation 61.67
|
330.71 ug/mL
Geometric Coefficient of Variation 23.09
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 2
|
195.09 ug/mL
Geometric Coefficient of Variation 12.59
|
221.76 ug/mL
Geometric Coefficient of Variation 31.09
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 3
|
270.80 ug/mL
Geometric Coefficient of Variation 57.38
|
222.00 ug/mL
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 6
|
288.80 ug/mL
|
205.70 ug/mL
Geometric Coefficient of Variation 13.62
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 9
|
222.80 ug/mL
|
—
|
|
Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 12
|
—
|
234.90 ug/mL
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
NA ug/mL
Geometric Coefficient of Variation NA
Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
|
NA ug/mL
Geometric Coefficient of Variation NA
Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=1 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
|
0.783 Ratio
Geometric Coefficient of Variation 16
|
0.925 Ratio
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=1 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
|
1.561 Ratio
Geometric Coefficient of Variation 30
|
1.909 Ratio
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=1 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
|
1.139 Ratio
Geometric Coefficient of Variation 26
|
1.075 Ratio
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
Blood samples were collected for PK analysis. Accumulation ratio for Ctrough was calculated as Ctrough at the visit divided by pre-dose at Cycle 2 Day 1.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=1 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
|
2.069 Ratio
|
1.775 Ratio
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Values were not calculated for some cycles since there were no sufficient data.
Blood samples were collected for PK analysis. Accumulation ratio for C-EOI was calculated as C-EOI at the visit divided by C-EOI at Cycle 1.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=1 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
0.603 Ratio
Geometric Coefficient of Variation 117
|
0.869 Ratio
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
5077.3323 h*ug/mL
Geometric Coefficient of Variation 13.10
|
5489.6508 h*ug/mL
Geometric Coefficient of Variation 25.39
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
6201.7657 h*ug/mL
Geometric Coefficient of Variation 18.62
|
6178.4350 h*ug/mL
Geometric Coefficient of Variation 30.75
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
5160.2733 h*ug/mL
Geometric Coefficient of Variation 10.83
|
5166.5353 h*ug/mL
Geometric Coefficient of Variation 31.90
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
24.684617 mL/h
Geometric Coefficient of Variation 4.44
|
20.900323 mL/h
Geometric Coefficient of Variation 7.20
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
|
47.62 ug/mL
Geometric Coefficient of Variation 25.07
|
61.70 ug/mL
Geometric Coefficient of Variation 26.51
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
0.00302685 1/h
Geometric Coefficient of Variation 15.54
|
0.00470710 1/h
Geometric Coefficient of Variation 59.70
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=2 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=3 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
6.801065 Liter (L)
Geometric Coefficient of Variation 4.67
|
4.537404 Liter (L)
Geometric Coefficient of Variation 22.01
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
8.825 Day
Interval 8.63 to 11.4
|
6.195 Day
Interval 3.09 to 11.95
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
21.080 Day
Interval 20.99 to 24.14
|
27.958 Day
Interval 6.93 to 27.98
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC)
|
0.780 hour (h)
Interval 0.72 to 1.85
|
1.865 hour (h)
Interval 0.82 to 2.2
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
46.34 ug/mL
Geometric Coefficient of Variation 27.07
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 4
|
34.80 ug/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 6
|
47.20 ug/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 9
|
35.90 ug/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 10
|
48.20 ug/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 11
|
25.60 ug/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 12
|
37.60 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ).
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 3
|
0.56 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
52.96 ug/mL
Geometric Coefficient of Variation 21.31
|
—
|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 2
|
34.30 ug/mL
|
—
|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 4
|
53.90 ug/mL
|
—
|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 10
|
52.10 ug/mL
|
—
|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 11
|
45.70 ug/mL
|
—
|
|
Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 24
|
32.00 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Ctrough values were not determined for cycles where the concentration values were below the Lower Limit of Quantification (LLOQ).
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
CYCLE 1
|
1.05 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
9213.7145 h*ug/mL
Geometric Coefficient of Variation 6.50
|
9590.8606 h*ug/mL
Geometric Coefficient of Variation 23.71
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. AUC(0-inf) were not calculated for some participants since there were no sufficient data.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
—
|
9921.8634 h*ug/mL
Geometric Coefficient of Variation 11.55
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
9471.9799 h*ug/mL
Geometric Coefficient of Variation 1.97
|
8495.7663 h*ug/mL
Geometric Coefficient of Variation 36.72
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
|
43.51 ug/mL
Geometric Coefficient of Variation 15.05
|
52.33 ug/mL
Geometric Coefficient of Variation 22.64
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
0.00159877 1/h
Geometric Coefficient of Variation 22.83
|
0.00305831 1/h
Geometric Coefficient of Variation 45.34
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed. Vss was not calculated for some participants as sufficient data was not available.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=2 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
—
|
4.367635 Liter (L)
Geometric Coefficient of Variation 9.29
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
16.172 Day
Interval 15.57 to 23.41
|
10.392 Day
Interval 5.18 to 14.3
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
21.080 Day
Interval 20.99 to 24.14
|
27.958 Day
Interval 6.93 to 27.98
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)
|
1.850 hour (h)
Interval 1.75 to 2.2
|
1.900 hour (h)
Interval 1.75 to 2.2
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
40.80 ug/mL
Geometric Coefficient of Variation 10.98
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 4
|
40.80 ug/mL
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 6
|
38.20 ug/mL
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 9
|
43.60 ug/mL
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 10
|
55.70 ug/mL
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 11
|
30.40 ug/mL
|
—
|
|
Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 12
|
35.20 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 3
|
2.11 ug/mL
|
—
|
|
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 5
|
0.84 ug/mL
|
—
|
|
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 8
|
1.77 ug/mL
|
—
|
|
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 10
|
1.41 ug/mL
|
—
|
|
Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 11
|
0.74 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
55.85 ug/mL
Geometric Coefficient of Variation 12.63
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 2
|
42.40 ug/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 4
|
46.30 ug/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 10
|
54.00 ug/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 11
|
71.40 ug/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 24
|
34.30 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=1 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 1
|
4.14 ug/mL
|
—
|
|
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 9
|
3.09 ug/mL
|
—
|
|
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)
CYCLE 23
|
0.82 ug/mL
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
80.0859 h*nanogram (ng)/mL
Geometric Coefficient of Variation 22.53
|
82.6253 h*nanogram (ng)/mL
Geometric Coefficient of Variation 42.28
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
857.63 picogram (pg)/mL
Geometric Coefficient of Variation 32.99
|
905.42 picogram (pg)/mL
Geometric Coefficient of Variation 28.37
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
6.942 Day
Interval 6.81 to 7.01
|
6.865 Day
Interval 3.9 to 7.79
|
SECONDARY outcome
Timeframe: Pre-dose, EOI, 2h and 24h post- Start of Infusion (SOI), Day 4, Day 8-15 in Cycle 1; Pre-Dose on Cycle 2 Day 1 (If Cycle 2 belantamab mafodotin dose was delayed, 1 PK sample was taken at 21 days post-SOI in Arm A or 28 days post-SOI in Arm B)Population: Pharmacokinetic population.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
22.370 h
Interval 22.05 to 23.07
|
22.950 h
Interval 22.03 to 24.15
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 4, Cycle 6, Cycle 9, Cycle 10, Cycle 11 and Cycle 12Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 1
|
319.85 pg/mL
Geometric Coefficient of Variation 29.78
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 4
|
399.10 pg/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 6
|
207.50 pg/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 9
|
88.60 pg/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 10
|
179.00 pg/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 11
|
232.00 pg/mL
|
—
|
|
Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 12
|
336.00 pg/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 3, Cycle 5, Cycle 8, Cycle 9, Cycle 10 and Cycle 11Population: Pharmacokinetic population. Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Cycle 2, Cycle 4, Cycle 10, Cycle 11 and Cycle 24Population: Pharmacokinetic population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 1
|
390.28 pg/mL
Geometric Coefficient of Variation 46.28
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 2
|
428.60 pg/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 4
|
499.80 pg/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 10
|
198.00 pg/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 11
|
269.00 pg/mL
|
—
|
|
Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
CYCLE 24
|
346.00 pg/mL
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Cycle 3, Cycle 9, Cycle 10 and Cycle 23Population: Pharmacokinetic population
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
|
NA pg/mL
Geometric Coefficient of Variation NA
Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 141 weeksPopulation: All treated population
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 212 weeksPopulation: All treated population
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 141 weeksPopulation: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Serum samples 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 approximately 212 weeksPopulation: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Serum samples 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 approximately 141 weeksPopulation: All treated population
ORR is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e. PR, very good partial response \[VGPR\], complete response \[CR\], and stringent complete response \[sCR\]) of best response, according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= 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 hour (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
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1 - Percentage of Participants With Overall Response Rate (ORR)
|
50 Percentage of Participants
Interval 6.8 to 93.2
|
25 Percentage of Participants
Interval 0.6 to 80.6
|
SECONDARY outcome
Timeframe: Up to approximately 212 weeksPopulation: All treated population
ORR is defined as the percentage of participants with a confirmed PR or better (i.e. PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2 - Percentage of Participants With ORR
|
100 Percentage of Participants
Interval 29.2 to 100.0
|
50 Percentage of Participants
Interval 6.8 to 93.2
|
SECONDARY outcome
Timeframe: Up to approximately 141 weeksPopulation: All treated population
CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 1: Clinical Benefit Rate (CBR)
|
50 Percentage of Participants
Interval 6.8 to 93.2
|
75 Percentage of Participants
Interval 19.4 to 99.4
|
SECONDARY outcome
Timeframe: Up to approximately 212 weeksPopulation: All treated population
CBR is defined as percentage of participants with a confirmed Minimal response (MR) or better (i.e. MR, PR, VGPR, CR, and sCR) of best response, according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR= CR as above PLUS normal serum 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-h urinary M-protein by \>=90% or to \<200 mg/24 h; MR= \>=25% but \<=49% reduction of serum M-protein and reduction in 24-h urine M-protein by 50-89%. In addition to the above listed criteria, if present at baseline, \>=50% reduction in the size (SPD) 4 of soft tissue plasmacytomas is also required.
Outcome measures
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=3 Participants
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 Participants
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
|---|---|---|
|
Part 2: Clinical Benefit Rate (CBR)
|
100 Percentage of Participants
Interval 29.2 to 100.0
|
50 Percentage of Participants
Interval 6.8 to 93.2
|
Adverse Events
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
n=3 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
n=4 participants at risk
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)
n=2 participants at risk
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intratumoural haematoma
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
1/2 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
Other adverse events
| Measure |
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
n=4 participants at risk
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
n=4 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
|
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
n=3 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
n=4 participants at risk
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
PACT Phase - ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
n=2 participants at risk
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
|
PACT Phase - ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dex (Pom/Dex)
n=2 participants at risk
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Blood and lymphatic system disorders
Leukopenia
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
66.7%
2/3 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Blood and lymphatic system disorders
Neutropenia
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
100.0%
3/3 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Eye disorders
Asthenopia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Eye disorders
Cataract
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Eye disorders
Corneal oedema
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Oral mucosa erosion
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
Dermatophytosis of nail
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Infections and infestations
Tinea nigra
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
2/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Amylase increased
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Blood alkaline phosphatase increased
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 7 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 19 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • Number of events 6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
50.0%
2/4 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
66.7%
2/3 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
66.7%
2/3 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Skin and subcutaneous tissue disorders
Asteatosis
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
25.0%
1/4 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
0.00%
0/2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 212 weeks for main study and up to approximately 74 weeks for PACT phase.
Safety population included all participants who received at least 1 dose of study treatment. MedDRA version 24.1 was used for Part 1 (P1) and 26.0 for Part 2 (P2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER