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NCT02653976 · OUTCOME

Progression-Free Survival

A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) · Source last updated 2024-01-26

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

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.

What was measured

Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Analysis population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).

Groups in this outcome

SP-02L (Darinaparsin for Injection)

SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days

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

Analysis denominator · Participants

GroupSource count
SP-02L (Darinaparsin for Injection)57

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
SP-02L (Darinaparsin for Injection)3.3Not reported1.94.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        4.2
        value
        3.3
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
dispersion Type
90% Confidence Interval
groups
  1. description
    SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
    id
    OG000
    title
    SP-02L (Darinaparsin for Injection)
param Type
MEDIAN
population Description
Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).
reporting Status
POSTED
time Frame
Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.
title
Progression-Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice