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NCT01170663 · OUTCOME

Overall Survival Time (OS)

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma · Source last updated 2019-09-18

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 27.5 months

What was measured

OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.

Analysis population: All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.

Groups in this outcome

Ramucirumab (IMC-1211B) Plus Paclitaxel

8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.

Placebo Plus Paclitaxel

Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab (IMC-1211B) Plus Paclitaxel330
Placebo Plus Paclitaxel335

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1211B) Plus Paclitaxel9.6Not reported8.510.8Not reported
Placebo Plus Paclitaxel7.4Not reported6.38.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.678
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.962
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0169
    param Type
    Hazard Ratio (HR)
    param Value
    0.807
    statistical Comment
    Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.
    statistical Method
    Stratified Log Rank Test
Complete source fields
analyses
  1. ci Lower Limit
    0.678
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.962
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0169
    param Type
    Hazard Ratio (HR)
    param Value
    0.807
    statistical Comment
    Adjusted for stratification factors: geographic region, time-to-progression from start of first-line therapy and disease measurability.
    statistical Method
    Stratified Log Rank Test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.5
        upper Limit
        10.8
        value
        9.6
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        8.4
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      330
    2. group Id
      OG001
      value
      335
    units
    Participants
description
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    id
    OG000
    title
    Ramucirumab (IMC-1211B) Plus Paclitaxel
  2. description
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    id
    OG001
    title
    Placebo Plus Paclitaxel
param Type
MEDIAN
population Description
All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.
reporting Status
POSTED
time Frame
Randomization up to 27.5 months
title
Overall Survival Time (OS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice