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NCT01423760 · OUTCOME

Overall Survival (OS)

Common Safety Follow-up Trial of Tecemotide (L-BLP25) · Source last updated 2016-10-06

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From randomization to death, assessed up to 3.6 years

What was measured

Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.

Analysis population: Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)

Groups in this outcome

Non-small Cell Lung Cancer (NSCLC)

Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.

Multiple Myeloma

Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.

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

Analysis denominator · Participants

GroupSource count
Non-small Cell Lung Cancer (NSCLC)0
Multiple Myeloma0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.
groups
  1. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
    id
    OG000
    title
    Non-small Cell Lung Cancer (NSCLC)
  2. description
    Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
    id
    OG001
    title
    Multiple Myeloma
population Description
Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)
reporting Status
POSTED
time Frame
From randomization to death, assessed up to 3.6 years
title
Overall Survival (OS)
type
SECONDARY

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

Preserved source evidence · Not medical advice