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NCT01213472 · OUTCOME

Number of Patients With Progression-free Survival Events

Evaluation of a New Anti-cancer Immunotherapy in Patients With Non-operable and Progressing Metastatic Cutaneous Melanoma · Source last updated 2019-10-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)

What was measured

Progression-free survival was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. PFS events included progressive disease (PD), death in absence of PD and events (Any event which was part of the natural course of the disease under study, was captured as an efficacy measure. Therefore it did not need to be reported as an SAE).

Analysis population: The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.

Groups in this outcome

NY-ESO 1 Group

Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.

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

Analysis denominator · Participants

GroupSource count
NY-ESO 1 Group33

Reported measurements

PD, Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group29Not reportedNot reportedNot reportedNot reported
PD, No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group4Not reportedNot reportedNot reportedNot reported
Death in absence of PD, Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group0Not reportedNot reportedNot reportedNot reported
Death in absence of PD, No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group33Not reportedNot reportedNot reportedNot reported
Events, Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group29Not reportedNot reportedNot reportedNot reported
Events, No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NY-ESO 1 Group4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    PD, Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    PD, No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Death in absence of PD, Yes
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Death in absence of PD, No
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    title
    Events, Yes
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Events, No
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
Progression-free survival was defined as the time from the date of registration of the patient to either the date of disease progression or the date of death (for whatever reason), whichever came first. Patients alive and without disease progression were censored at the date of their last tumor evaluation. PFS events included progressive disease (PD), death in absence of PD and events (Any event which was part of the natural course of the disease under study, was captured as an efficacy measure. Therefore it did not need to be reported as an SAE).
groups
  1. description
    Patients with non-operable and progressing metastatic cutaneous melanoma, received up to 24 doses of GSK2241658A Cancer Immunotherapeutic, provided that at each tumor evaluation time point, the clinical criteria to continue the treatment were met, including patients having a clinical response.
    id
    OG000
    title
    NY-ESO 1 Group
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis was performed on the total treated cohort (TTC), which included all subjects who received at least one dose of the Antigen-Specific Cancer Immunotherapeutic (ASCI) treatment.
reporting Status
POSTED
time Frame
From first treatment administration (i.e. at Week 0) until the last tumor evaluation (i.e. at Month 49)
title
Number of Patients With Progression-free Survival Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice