NCT03848845 · OUTCOME

Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision

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: Up to approximately 178 weeks

What was measured

A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score.

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 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg 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

Group	Source count
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	10

Reported measurements

One

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	6	Not reported	Not reported	Not reported	Not reported

Two

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	1	Not reported	Not reported	Not reported	Not reported

Three or more

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
title
One
categories
measurements
group Id
OG000
value
1
title
Two
categories
measurements
group Id
OG000
value
3
title
Three or more

denoms

counts
group Id
OG000
value
10
units
Participants

description

A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score.

groups

description
Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg 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
OG000
title
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion

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

Up to approximately 178 weeks

title

Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice