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NCT00917384 · OUTCOME

Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Week 12 post-randomization

What was measured

The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.

Analysis population: Intent-to-treat population: all randomized participants.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMC-1121B (Ramucirumab)40.1Not reported33.646.4Not reported
Placebo15.8Not reported9.723.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    14.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Difference Between Arms
    param Value
    24.2
    statistical Method
    Normal Approximation
Complete source fields
analyses
  1. ci Lower Limit
    14.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    33.6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    <0.0001
    param Type
    Difference Between Arms
    param Value
    24.2
    statistical Method
    Normal Approximation
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.6
        upper Limit
        46.4
        value
        40.1
      2. group Id
        OG001
        lower Limit
        9.7
        upper Limit
        23.3
        value
        15.8
denoms
  1. counts
    1. group Id
      OG000
      value
      238
    2. group Id
      OG001
      value
      117
    units
    Participants
description
The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.
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
NUMBER
population Description
Intent-to-treat population: all randomized participants.
reporting Status
POSTED
time Frame
Week 12 post-randomization
title
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice