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NCT02064387 · OUTCOME

Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (MM)

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

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 and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)

What was measured

The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to \<60 bpm and increase to \>100 bpm) and change in temperature from Baseline(increase to \>=38 or decrease to \<=35 degrees celsius). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.

Analysis population: Part 2 MM Population

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (MM)

Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).

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

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)35

Reported measurements

HR, decrease to <60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)9Not reportedNot reportedNot reportedNot reported
HR, change to normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)17Not reportedNot reportedNot reportedNot reported
HR, increase to >100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)10Not reportedNot reportedNot reportedNot reported
Temp, decrease to <=35
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)1Not reportedNot reportedNot reportedNot reported
Temp, change to normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)29Not reportedNot reportedNot reportedNot reported
Temp, increase to >=38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    HR, decrease to <60
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    HR, change to normal or no change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    HR, increase to >100
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Temp, decrease to <=35
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Temp, change to normal or no change
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Temp, increase to >=38
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to \<60 bpm and increase to \>100 bpm) and change in temperature from Baseline(increase to \>=38 or decrease to \<=35 degrees celsius). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
groups
  1. description
    Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (MM)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 MM Population
reporting Status
POSTED
time Frame
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
title
Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (MM)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice