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NCT01456039 · OUTCOME

Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER

A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL) · Source last updated 2019-02-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Median follow-up time was 100 days; up to the data cut-off of 28 July 2015

What was measured

TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.

Analysis population: Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)

Groups in this outcome

Phase 1: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Phase 2: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

Total: Romidepsin 14mg/m^2

Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Phase 1: Romidepsin 14mg/m^21
Phase 2: Romidepsin 14mg/m^217
Total: Romidepsin 14mg/m^218

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: Romidepsin 14mg/m^2737.0Not reported737.0737.0Not reported
Phase 2: Romidepsin 14mg/m^256.0Not reported50.071.0Not reported
Total: Romidepsin 14mg/m^256.0Not reported50.0737.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        737.0
        upper Limit
        737.0
        value
        737.0
      2. group Id
        OG001
        lower Limit
        50.0
        upper Limit
        71.0
        value
        56.0
      3. group Id
        OG002
        lower Limit
        50.0
        upper Limit
        737.0
        value
        56.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      18
    units
    Participants
description
TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.
dispersion Type
Full Range
groups
  1. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG000
    title
    Phase 1: Romidepsin 14mg/m^2
  2. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG001
    title
    Phase 2: Romidepsin 14mg/m^2
  3. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG002
    title
    Total: Romidepsin 14mg/m^2
param Type
MEDIAN
population Description
Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)
reporting Status
POSTED
time Frame
Median follow-up time was 100 days; up to the data cut-off of 28 July 2015
title
Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice