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NCT03349333 · OUTCOME

Duration of Responses

A Single Arm Study Evaluating the Efficacy and Safety of Pralatrexate in Subjects With Relapsed or Refractory PTCL · Source last updated 2019-10-01

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
4 years

What was measured

Duration of response was measured from first day of documented response to disease progression or death, whatever comes first.

Analysis population: The secondary analyses was performed using the safety population and repeated using the per-protocol population.

Groups in this outcome

Pralatrexate

Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Pralatrexate71

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pralatrexate8.67Not reported3.3214.13Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.32
        upper Limit
        14.13
        value
        8.67
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Duration of response was measured from first day of documented response to disease progression or death, whatever comes first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Vitamin B12 and folic acid will be taken concurrently with pralatrexate pralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle. Vitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
    id
    OG000
    title
    Pralatrexate
param Type
MEDIAN
population Description
The secondary analyses was performed using the safety population and repeated using the per-protocol population.
reporting Status
POSTED
time Frame
4 years
title
Duration of Responses
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice