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NCT03525678 · OUTCOME

Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

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 186 weeks

What was measured

Following parameters were assessed:basophils,eosinophils,hematocrit,mean corpuscular hemoglobin (MCH),MCH concentration,MC volume,monocyte,erythrocytes, reticulocytes.Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range\[LNR\]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.

Analysis population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

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: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)99
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24

Reported measurements

Basophils, decrease to low, n=94,96,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)2Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)7Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Basophils, change to normal or NC, n=94,96,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)87Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)85Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)19Not reportedNot reportedNot reportedNot reported
Basophils, increase to high, n=94,96,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)4Not reportedNot reportedNot reportedNot reported
Eosinophils, decrease to low, n=95,97,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)14Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)13Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Eosinophils, change to normal or NC, n=95,97,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)71Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)78Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)16Not reportedNot reportedNot reportedNot reported
Eosinophils, increase to high, n=95,97,23

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)8Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)7Not reportedNot reportedNot reportedNot reported
Hematocrit, decrease to low, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)1Not reportedNot reportedNot reportedNot reported
Hematocrit, change to normal or NC, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)84Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)94Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)23Not reportedNot reportedNot reportedNot reported
Hematocrit, increase to high, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)14Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)17Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)5Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)79Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)68Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)14Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Hemoglobin, increase to high, n=95,95,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)2Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)12Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)2Not reportedNot reportedNot reportedNot reported
MCH Concentration, decrease to low, n=94,96,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)20Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)28Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)6Not reportedNot reportedNot reportedNot reported
MCH Concentration, change to normal or NC, n=94,96,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)70Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)66Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)14Not reportedNot reportedNot reportedNot reported
MCH Concentration, increase to high, n=94,96,21

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)94
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)96
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)2Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)1Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Volume, decrease to low, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)12Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)15Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)4Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Volume, change to normal or NC, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)77Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)73Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)18Not reportedNot reportedNot reportedNot reported
Mean Corpuscular Volume, increase to high, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)7Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)3Not reportedNot reportedNot reportedNot reported
Monocytes, decrease to low, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)6Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)1Not reportedNot reportedNot reportedNot reported
Monocytes, change to normal or NC, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)62Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)50Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)12Not reportedNot reportedNot reportedNot reported
Monocytes, increase to high, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)28Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)45Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)12Not reportedNot reportedNot reportedNot reported
Erythrocytes, decrease to low, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)4Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)1Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Erythrocytes, change to normal or NC, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)91Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)95Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)21Not reportedNot reportedNot reportedNot reported
Erythrocytes, increase to high, n=95,97,24

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)2Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)1Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)3Not reportedNot reportedNot reportedNot reported
Reticulocytes, decrease to low, n=73,65,19

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)73
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)65
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)19
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)11Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)15Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)7Not reportedNot reportedNot reportedNot reported
Reticulocytes, change to normal or NC, n=73,65,19

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)73
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)65
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)19
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)49Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)33Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)3Not reportedNot reportedNot reportedNot reported
Reticulocytes, increase to high, n=73,65,19

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)73
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)65
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)19
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)16Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)21Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        96
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Basophils, decrease to low, n=94,96,23
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        87
      2. group Id
        OG001
        value
        85
      3. group Id
        OG002
        value
        19
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        96
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Basophils, change to normal or NC, n=94,96,23
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        96
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Basophils, increase to high, n=94,96,23
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Eosinophils, decrease to low, n=95,97,23
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        78
      3. group Id
        OG002
        value
        16
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Eosinophils, change to normal or NC, n=95,97,23
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        23
      units
      Participants
    title
    Eosinophils, increase to high, n=95,97,23
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Hematocrit, decrease to low, n=95,97,24
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        94
      3. group Id
        OG002
        value
        23
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Hematocrit, change to normal or NC, n=95,97,24
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        24
      units
      Participants
    title
    Hematocrit, increase to high, n=95,97,24
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        17
      3. group Id
        OG002
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        95
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    Mean Corpuscular Hemoglobin, decrease to low, n=95,95,21
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        68
      3. group Id
        OG002
        value
        14
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        95
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    Mean Corpuscular Hemoglobin, change to normal or NC, n=95,95,21
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        95
      3. group Id
        OG002
        value
        21
      units
      Participants
    title
    Mean Corpuscular Hemoglobin, increase to high, n=95,95,21
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Following parameters were assessed:basophils,eosinophils,hematocrit,mean corpuscular hemoglobin (MCH),MCH concentration,MC volume,monocyte,erythrocytes, reticulocytes.Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range\[LNR\]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
groups
  1. description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    OG000
    title
    Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
  2. description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    OG001
    title
    Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
  3. description
    Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
    id
    OG002
    title
    Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
Baseline (Day 1) and Up to 186 weeks
title
Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range
type
SECONDARY
unit Of Measure
Participants

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