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NCT02064387 · OUTCOME

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

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 7.2 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 NHL Population

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (NHL)

Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 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 (NHL)6

Reported measurements

HR, decrease to <60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)3Not 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 (NHL)2Not reportedNot reportedNot reportedNot reported
HR, increase to >100
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Temp, decrease to <=35
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not 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 (NHL)5Not reportedNot reportedNot reportedNot reported
Temp, increase to >=38
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    HR, decrease to <60
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    HR, change to normal or no change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    HR, increase to >100
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Temp, decrease to <=35
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Temp, change to normal or no change
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Temp, increase to >=38
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    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 non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 NHL Population
reporting Status
POSTED
time Frame
Baseline and Up to 7.2 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 (NHL)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice