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NCT01822886 · OUTCOME

Percentage of Participants With Progression-Free Survival

Phase II Study of Gemcitabine+Romidepsin in the Relapsed/Refractory Peripheral T-cell Lymphoma Patients · Source last updated 2019-10-14

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

Measure
NUMBER
Unit
percentage of partecipants
Interval / dispersion
95% Confidence Interval
Time frame
24 months

What was measured

The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS (progression-free survival) data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day. Percentage of participants is an estimate based on Kaplan-Meier method.

Groups in this outcome

Romidepsin, Gemcitabine

Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.

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

Analysis denominator · Participants

GroupSource count
Romidepsin, Gemcitabine20

Reported measurements

Source class 1
Values in percentage of partecipants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Romidepsin, Gemcitabine11.2Not reported325Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        25
        value
        11.2
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS (progression-free survival) data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day. Percentage of participants is an estimate based on Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Romidepsin 12 mg/m2 d.1,8, 15 + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD Romidepsin, Gemcitabine: Romidepsin 12 mg/m2 d.1,8, 15 for 6 cycles + Gemcitabine 800 mg/m2 d.1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 d. 1, 15 to PD.
    id
    OG000
    title
    Romidepsin, Gemcitabine
param Type
NUMBER
reporting Status
POSTED
time Frame
24 months
title
Percentage of Participants With Progression-Free Survival
type
SECONDARY
unit Of Measure
percentage of partecipants

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

Preserved source evidence · Not medical advice