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NCT03848845 · OUTCOME

Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters

Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline (Day 1) and up to approximately 31 months

What was measured

Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.

Analysis population: All Treated Population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.

Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation

Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7

Reported measurements

Glucose Increased (Hyperglycemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Glucose Increased (Hyperglycemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Glucose Increased (Hyperglycemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Glucose Decreased (Hypoglycemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Glucose Decreased (Hypoglycemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Glucose Decreased (Hypoglycemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
ALT Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation3Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
ALT Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
ALT Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Albumin Decreased (Hypoalbuminemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4Not reportedNot reportedNot reportedNot reported
Albumin Decreased (Hypoalbuminemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Albumin Decreased (Hypoalbuminemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation3Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
AST Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation5Not reportedNot reportedNot reportedNot reported
AST Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
AST Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Blood bilirubin Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Blood bilirubin Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Blood bilirubin Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Calcium Increased (Hypercalcemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Calcium Increased (Hypercalcemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Calcium Increased (Hypercalcemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Calcium Decreased (Hypocalcemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Calcium Decreased (Hypocalcemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Calcium Decreased (Hypocalcemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation5
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
CPK Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
CPK Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
CPK Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Creatinine Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Creatinine Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Creatinine Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
GGT Increased, Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation3Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
GGT Increased, Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
GGT Increased, Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Magnesium Increased (Hypermagnesemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Magnesium Increased (Hypermagnesemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Magnesium Increased (Hypermagnesemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Magnesium Decreased (Hypomagnesemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Magnesium Decreased (Hypomagnesemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Magnesium Decreased (Hypomagnesemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Phosphate Decreased (Hypophosphatemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Phosphate Decreased (Hypophosphatemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Phosphate Decreased (Hypophosphatemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Potassium Increased (Hyperkalemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Potassium Increased (Hyperkalemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Potassium Increased (Hyperkalemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Potassium Decreased (Hypokalemia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Potassium Decreased (Hypokalemia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Potassium Decreased (Hypokalemia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Sodium Increased (Hypernatremia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Sodium Increased (Hypernatremia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Sodium Increased (Hypernatremia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Sodium Decreased (Hyponatremia), Any Grade Increase

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation1Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation3Not reportedNot reportedNot reportedNot reported
Sodium Decreased (Hyponatremia), Increase to Grade 3

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation2Not reportedNot reportedNot reportedNot reported
Sodium Decreased (Hyponatremia), Increase to Grade 4

Analysis denominator · Participants

GroupSource count
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation6
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation7
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Increased (Hyperglycemia), Any Grade Increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Increased (Hyperglycemia), Increase to Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Increased (Hyperglycemia), Increase to Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Decreased (Hypoglycemia), Any Grade Increase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Decreased (Hypoglycemia), Increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Glucose Decreased (Hypoglycemia), Increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    ALT Increased, Any Grade Increase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    ALT Increased, Increase to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    ALT Increased, Increase to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Albumin Decreased (Hypoalbuminemia), Any Grade Increase
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Albumin Decreased (Hypoalbuminemia), Increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      units
      Participants
    title
    Albumin Decreased (Hypoalbuminemia), Increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
groups
  1. description
    Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
    id
    OG000
    title
    Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation
  2. description
    Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
    id
    OG001
    title
    Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 31 months
title
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice