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NCT02064387 · OUTCOME

Change From Baseline in Urine Protein Excretion (24 Hour)-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
MEAN
Unit
Grams per day
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)

What was measured

Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented

Analysis population: Part 2 MM Population. 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

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

Day 1 (Cycle 2), n=24

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)24
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.51.21Not reportedNot reportedNot reported
Day 1 (Cycle 3), n=18

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)18
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.71.29Not reportedNot reportedNot reported
Day 1 (Cycle 4), n=13

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)13
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.71.65Not reportedNot reportedNot reported
Day 1 (Cycle 5), n=15

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)15
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.71.66Not reportedNot reportedNot reported
Day 1 (Cycle 6), n=14

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)14
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.81.69Not reportedNot reportedNot reported
Day 1 (Cycle 7), n=14

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)14
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.91.56Not reportedNot reportedNot reported
Day 1 (Cycle 8), n=16

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)16
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.71.53Not reportedNot reportedNot reported
Day 1 (Cycle 9), n=13

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)13
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.51.01Not reportedNot reportedNot reported
Day 1 (Cycle 10), n=12

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)12
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.06Not reportedNot reportedNot reported
Day 1 (Cycle 11), n=10

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)10
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.01Not reportedNot reportedNot reported
Day 1 (Cycle 12), n=10

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)10
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.11Not reportedNot reportedNot reported
Day 1 (Cycle 13), n=9

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)9
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.27Not reportedNot reportedNot reported
Day 1 (Cycle 14), n=9

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)9
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.25Not reportedNot reportedNot reported
Day 1 (Cycle 15), n=9

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)9
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.41.30Not reportedNot reportedNot reported
Day 1 (Cycle 16), n=9

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)9
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)-0.31.35Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.21
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Day 1 (Cycle 2), n=24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.29
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      units
      Participants
    title
    Day 1 (Cycle 3), n=18
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.65
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Day 1 (Cycle 4), n=13
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.66
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Day 1 (Cycle 5), n=15
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.69
        value
        -0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Day 1 (Cycle 6), n=14
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.56
        value
        -0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    Day 1 (Cycle 7), n=14
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.53
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Day 1 (Cycle 8), n=16
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.01
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    Day 1 (Cycle 9), n=13
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.06
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    Day 1 (Cycle 10), n=12
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.01
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Day 1 (Cycle 11), n=10
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.11
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      units
      Participants
    title
    Day 1 (Cycle 12), n=10
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.27
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      units
      Participants
    title
    Day 1 (Cycle 13), n=9
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
dispersion Type
Standard Deviation
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
MEAN
population Description
Part 2 MM Population. 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 and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
title
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (MM)
type
PRIMARY
unit Of Measure
Grams per day

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

Preserved source evidence · Not medical advice