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NCT03168438 · OUTCOME

Number of Participants With Worst-case Results for Coagulation Parameters Relative to Normal Range Post-Baseline Relative to Baseline

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma · Source last updated 2022-01-11

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
Up to 108 weeks

What was measured

Blood samples were collected for the assessment of following coagulation parameters: prothrombin time and partial thromboplastin time (PTT). A laboratory value that is outside the normal range is considered either high abnormal (value above the upper limit of the normal range) or low abnormal (value below the lower limit of the normal range). Participants were counted twice if the participant had values in 'Decreased to low' and 'Increased to high' during the post-Baseline period. Data for worst case post Baseline is presented.

Analysis population: Modified ITT Population. Only those participants with data available at the specified time point is reported

Groups in this outcome

GSK3377794

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.

GSK3377794+Pembrolizumab

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
GSK33777941
GSK3377794+Pembrolizumab0

Reported measurements

Prothrombin Time; decrease to low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
Prothrombin Time; To normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
Prothrombin Time; increase to high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
PTT; decrease to low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
PTT; To normal or no change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
PTT; increase to high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Prothrombin Time; decrease to low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Prothrombin Time; To normal or no change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Prothrombin Time; increase to high
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    PTT; decrease to low
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    PTT; To normal or no change
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    PTT; increase to high
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Blood samples were collected for the assessment of following coagulation parameters: prothrombin time and partial thromboplastin time (PTT). A laboratory value that is outside the normal range is considered either high abnormal (value above the upper limit of the normal range) or low abnormal (value below the lower limit of the normal range). Participants were counted twice if the participant had values in 'Decreased to low' and 'Increased to high' during the post-Baseline period. Data for worst case post Baseline is presented.
groups
  1. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
    id
    OG000
    title
    GSK3377794
  2. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
    id
    OG001
    title
    GSK3377794+Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Modified ITT Population. Only those participants with data available at the specified time point is reported
reporting Status
POSTED
time Frame
Up to 108 weeks
title
Number of Participants With Worst-case Results for Coagulation Parameters Relative to Normal Range Post-Baseline Relative to Baseline
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice