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NCT01170663 · OUTCOME

Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline up to 103 weeks and within 30 days of last dose of study drug

What was measured

Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

Analysis population: All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.

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 Paclitaxel327
Placebo Plus Paclitaxel329

Reported measurements

SAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1211B) Plus Paclitaxel161Not reportedNot reportedNot reportedNot reported
Placebo Plus Paclitaxel146Not reportedNot reportedNot reportedNot reported
Other Non-serious AEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1211B) Plus Paclitaxel324Not reportedNot reportedNot reportedNot reported
Placebo Plus Paclitaxel321Not reportedNot reportedNot reportedNot reported
Died
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1211B) Plus Paclitaxel37Not reportedNot reportedNot reportedNot reported
Placebo Plus Paclitaxel52Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        146
    title
    SAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        324
      2. group Id
        OG001
        value
        321
    title
    Other Non-serious AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        52
    title
    Died
denoms
  1. counts
    1. group Id
      OG000
      value
      327
    2. group Id
      OG001
      value
      329
    units
    Participants
description
Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
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
NUMBER
population Description
All randomized participants who received at least 1 dose of study drug and based on the treatment each participant received.
reporting Status
POSTED
time Frame
Baseline up to 103 weeks and within 30 days of last dose of study drug
title
Number of Participants With Serious and Other Non-serious Adverse Events (AE) and Who Died
type
OTHER_PRE_SPECIFIED
unit Of Measure
participants

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

Preserved source evidence · Not medical advice