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NCT02064387 · OUTCOME

Number of Participants With Antibodies to GSK2857916 in Serum Over Time - 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, Day 1 (Cycle 2, 3), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)

What was measured

Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.

Analysis population: Part 2 NHL 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 (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)5

Reported measurements

Baseline, screening, positive, n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Baseline, screening, negative n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)5Not reportedNot reportedNot reportedNot reported
Baseline, confirming, positive, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
Baseline, confirming, negative, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
Baseline, negative, conclusive, n=5

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)5Not reportedNot reportedNot reportedNot reported
Cycle 2, Day 1, screening, positive, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Cycle 2, Day 1, screening, negative, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)4Not reportedNot reportedNot reportedNot reported
Cycle 2, Day 1, confirming, positive, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
Cycle 2, Day 1, confirming, negative, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
Cycle 2, Day 1, negative, conclusive, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)4Not reportedNot reportedNot reportedNot reported
Cycle 3, Day 1, screening, positive, n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Cycle 3, Day 1, screening, negative, n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Cycle 3, Day 1, confirming, positive, n=1

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Cycle 3, Day 1, confirming, negative, n=1

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
Cycle 3, Day 1, negative, conclusive, n=2

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)1Not reportedNot reportedNot reportedNot reported
End of study, screening, positive, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
End of study, screening, negative, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)4Not reportedNot reportedNot reportedNot reported
End of study, confirming, positive, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
End of study, confirming, negative, n=0

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)0
End of study, negative, conclusive, n=4

Analysis denominator · Participants

GroupSource count
Part 2: GSK2857916 3.40 mg/kg (NHL)4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Baseline, screening, positive, n=5
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Baseline, screening, negative n=5
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Baseline, confirming, positive, n=0
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Baseline, confirming, negative, n=0
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Baseline, negative, conclusive, n=5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2, Day 1, screening, positive, n=4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2, Day 1, screening, negative, n=4
  8. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 2, Day 1, confirming, positive, n=0
  9. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle 2, Day 1, confirming, negative, n=0
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Cycle 2, Day 1, negative, conclusive, n=4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 3, Day 1, screening, positive, n=2
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Cycle 3, Day 1, screening, negative, n=2
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints 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. 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 (Cycle 2, 3), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
title
Number of Participants With Antibodies to GSK2857916 in Serum Over Time - Part 2 (NHL)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice