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NCT02064387 · OUTCOME

Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -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

Urine samples were collected to assess urine OB and urine Pro. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was 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. 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

OB,No change/decreased, n=33

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)18Not reportedNot reportedNot reportedNot reported
OB,Increase to small, n=33

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)14Not reportedNot reportedNot reportedNot reported
OB,Increase to moderate, n=33

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)1Not reportedNot reportedNot reportedNot reported
OB,Increase to large, n=33

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Pro,No change/decreased, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)15Not reportedNot reportedNot reportedNot reported
Pro,Increase to trace, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)11Not reportedNot reportedNot reportedNot reported
Pro,Increase to 1+, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)1Not reportedNot reportedNot reportedNot reported
Pro,Increase to 2+, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Pro,Increase to 3+, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)0Not reportedNot reportedNot reportedNot reported
Pro,Unknown, n=31

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (MM)31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (MM)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    OB,No change/decreased, n=33
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    OB,Increase to small, n=33
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    OB,Increase to moderate, n=33
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    OB,Increase to large, n=33
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,No change/decreased, n=31
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,Increase to trace, n=31
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,Increase to 1+, n=31
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,Increase to 2+, n=31
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,Increase to 3+, n=31
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Pro,Unknown, n=31
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Urine samples were collected to assess urine OB and urine Pro. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was 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. 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 Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
title
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (MM)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice