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NCT01822886 · OUTCOME

Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death

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

OS (overall survival) is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive.

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, Gemcitabine50Not reported2872Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28
        upper Limit
        72
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
OS (overall survival) is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive.
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
Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death
type
SECONDARY
unit Of Measure
percentage of partecipants

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

Preserved source evidence · Not medical advice