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NCT00917384 · OUTCOME

Overall Survival (OS)

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma · Source last updated 2019-09-25

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
Randomization up to 28 months post-randomization

What was measured

Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive

Analysis population: Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.

Groups in this outcome

IMC-1121B (Ramucirumab)

Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.

Placebo

Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
IMC-1121B (Ramucirumab)238
Placebo117

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMC-1121B (Ramucirumab)5.2Not reported4.45.7Not reported
Placebo3.8Not reported2.84.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.603
    ci Pct Value
    95
    ci Upper Limit
    0.998
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0473
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).
    statistical Method
    Stratified Log-Rank Test
Complete source fields
analyses
  1. ci Lower Limit
    0.603
    ci Pct Value
    95
    ci Upper Limit
    0.998
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0473
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratified Log-Rank Test and HR stratified by randomization strata (weight loss over the prior 3 months, primary tumor site and geographical region).
    statistical Method
    Stratified Log-Rank Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.4
        upper Limit
        5.7
        value
        5.2
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        4.7
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      117
    units
    Participants
description
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    id
    OG000
    title
    IMC-1121B (Ramucirumab)
  2. description
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.
reporting Status
POSTED
time Frame
Randomization up to 28 months post-randomization
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice