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NCT01456039 · OUTCOME

Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 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
95% Confidence Interval
Time frame
Median follow-up time was 100 days; up to the data cut-off of 28 July 2015

What was measured

Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression

Analysis population: ITT includes all participants who received at least one dose of romidepsin

Groups in this outcome

Phase 1: Cohort 1: Romidepsin 9mg/m^2

Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle

Phase 1: Cohort 2: 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: Cohort 1: Romidepsin 9mg/m^22
Phase 1: Cohort 2: Romidepsin 14mg/m^26
Phase 2: Romidepsin 14mg/m^240
Total: Romidepsin 14mg/m^246

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Cohort 1: Romidepsin 9mg/m^2114.00Not reportedNANANot estimable due to the low number of events
Phase 1: Cohort 2: Romidepsin 14mg/m^2899.00Not reported112.00899.00Not reported
Phase 2: Romidepsin 14mg/m^2170.00Not reported99.00392.00Not reported
Total: Romidepsin 14mg/m^2179.00Not reported101.00392.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to the low number of events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        114.00
      2. group Id
        OG001
        lower Limit
        112.00
        upper Limit
        899.00
        value
        899.00
      3. group Id
        OG002
        lower Limit
        99.00
        upper Limit
        392.00
        value
        170.00
      4. group Id
        OG003
        lower Limit
        101.00
        upper Limit
        392.00
        value
        179.00
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      40
    4. group Id
      OG003
      value
      46
    units
    Participants
description
Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression
dispersion Type
95% Confidence Interval
groups
  1. description
    Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
    id
    OG000
    title
    Phase 1: Cohort 1: Romidepsin 9mg/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 1: Cohort 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
    Phase 2: Romidepsin 14mg/m^2
  4. description
    Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
    id
    OG003
    title
    Total: Romidepsin 14mg/m^2
param Type
MEDIAN
population Description
ITT includes all participants who received at least one dose of romidepsin
reporting Status
POSTED
time Frame
Median follow-up time was 100 days; up to the data cut-off of 28 July 2015
title
Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 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