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NCT02653976 · OUTCOME

Overall 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
Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.

What was measured

Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.

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)17.4Not reported10.323.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        23.3
        value
        17.4
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.
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
Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice