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NCT01875237 · OUTCOME

To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.

Donor Lymphocyte Infusion (DLI) of T-cells Genetically Modified With iCasp9 Suicide Gene · Source last updated 2019-07-16

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
Day 3, 7, 14, 28, and 56 post-administration of AP1903.

What was measured

To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903.

Analysis population: Patient who received AP1903

Groups in this outcome

Transplant Only

Patients who did not move forward to DLI

Transplat Plus DLI

Proceeded to DLI per protocol

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

Analysis denominator · Participants

GroupSource count
Transplant Only0
Transplat Plus DLI1

Reported measurements

Day 3 post-administration of AP1903.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Transplant Only0Not reportedNot reportedNot reportedNot reported
Transplat Plus DLI1Not reportedNot reportedNot reportedNot reported
Day 7 post-administration of AP1903.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Transplant Only0Not reportedNot reportedNot reportedNot reported
Transplat Plus DLI1Not reportedNot reportedNot reportedNot reported
Day 14 post-administration of AP1903.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Transplant Only0Not reportedNot reportedNot reportedNot reported
Transplat Plus DLI1Not reportedNot reportedNot reportedNot reported
Day 28 post-administration of AP1903.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Transplant Only0Not reportedNot reportedNot reportedNot reported
Transplat Plus DLI1Not reportedNot reportedNot reportedNot reported
Day 56 post-administration of AP1903.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Transplant Only0Not reportedNot reportedNot reportedNot reported
Transplat Plus DLI1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Day 3 post-administration of AP1903.
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Day 7 post-administration of AP1903.
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Day 14 post-administration of AP1903.
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Day 28 post-administration of AP1903.
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Day 56 post-administration of AP1903.
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    units
    Participants
description
To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903.
groups
  1. description
    Patients who did not move forward to DLI
    id
    OG000
    title
    Transplant Only
  2. description
    Proceeded to DLI per protocol
    id
    OG001
    title
    Transplat Plus DLI
param Type
COUNT_OF_PARTICIPANTS
population Description
Patient who received AP1903
reporting Status
POSTED
time Frame
Day 3, 7, 14, 28, and 56 post-administration of AP1903.
title
To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice