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NCT03848845 · OUTCOME

Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature

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

Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.

Analysis population: All Treated Population

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

Pulse Rate

Baseline To Low

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

Baseline To Normal or No Change

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 Escalation3Not reportedNot reportedNot reportedNot reported

Baseline To High

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
Temperature

Baseline To Low

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

Baseline To Normal or No Change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation4Not reportedNot reportedNot reportedNot reported
Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation6Not reportedNot reportedNot reportedNot reported

Baseline To High

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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      title
      Baseline To Low
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      title
      Baseline To Normal or No Change
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      title
      Baseline To High
    title
    Pulse Rate
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      title
      Baseline To Low
    2. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      title
      Baseline To Normal or No Change
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      title
      Baseline To High
    title
    Temperature
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
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
reporting Status
POSTED
time Frame
Baseline (Day 1) and up to approximately 31 months
title
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice