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NCT02064387 · OUTCOME

Number of Participants With Grade Change From Baseline in Hematology Data-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

Blood samples were collected for the analysis of following hematology parameters: Hb, Lymph, Neutro, PC, and leuko. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits.An increase is defined as an increase in CTCAE grade relative to Baseline grade. 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

Hb, Hb increased, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)1Not reportedNot reportedNot reportedNot reported
Hb, Hb increased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Hb, Hb increased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Hb,Anemia, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)18Not reportedNot reportedNot reportedNot reported
Hb, Anemia, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)7Not reportedNot reportedNot reportedNot reported
Hb, Anemia, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count increased, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)3Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count increased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count increased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count decreased, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)18Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count decreased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)8Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count decreased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)2Not reportedNot reportedNot reportedNot reported
Neutro, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)15Not reportedNot reportedNot reportedNot reported
Neutro, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)2Not reportedNot reportedNot reportedNot reported
Neutro, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)5Not reportedNot reportedNot reportedNot reported
PC, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)32Not reportedNot reportedNot reportedNot reported
PC, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)13Not reportedNot reportedNot reportedNot reported
PC, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)3Not reportedNot reportedNot reportedNot reported
Leuko, Leukocytosis, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Leuko, Leukocytosis, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Leuko, Leukocytosis, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Leuko, Leuko decreased, any grade increase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)16Not reportedNot reportedNot reportedNot reported
Leuko, Leuko decreased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)4Not reportedNot reportedNot reportedNot reported
Leuko, Leuko decreased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hb, Hb increased, any grade increase
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hb, Hb increased, increase to Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hb, Hb increased, increase to Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Hb,Anemia, any grade increase
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Hb, Anemia, increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Hb, Anemia, increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Lymph, Lymph count increased, any grade increase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Lymph, Lymph count increased, increase to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Lymph, Lymph count increased, increase to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Lymph, Lymph count decreased, any grade increase
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Lymph, Lymph count decreased, increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Lymph, Lymph count decreased, increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Blood samples were collected for the analysis of following hematology parameters: Hb, Lymph, Neutro, PC, and leuko. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits.An increase is defined as an increase in CTCAE grade relative to Baseline grade. 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 Grade Change From Baseline in Hematology Data-Part 2 (MM)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice