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NCT01168973 · OUTCOME

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · 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
participants
Interval / dispersion
Not reported
Time frame
First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)

What was measured

Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (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: Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.

Groups in this outcome

Ramucirumab and Docetaxel

On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

Placebo and Docetaxel

On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

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 and Docetaxel627
Placebo and Docetaxel618

Reported measurements

At least 1 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel613Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel594Not reportedNot reportedNot reportedNot reported
At least 1 Grade 3, 4, or 5 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel495Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel444Not reportedNot reportedNot reportedNot reported
At least 1 treatment-emergent SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel269Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel262Not reportedNot reportedNot reportedNot reported
TEAE leading to study drug discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel58Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel32Not reportedNot reportedNot reportedNot reported
TEAE leading to death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel34Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel35Not reportedNot reportedNot reportedNot reported
Deaths While On Treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel428Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel451Not reportedNot reportedNot reportedNot reported
Deaths During 30 Days Post Last Dose
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel53Not reportedNot reportedNot reportedNot reported
Placebo and Docetaxel58Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        613
      2. group Id
        OG001
        value
        594
    title
    At least 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        495
      2. group Id
        OG001
        value
        444
    title
    At least 1 Grade 3, 4, or 5 TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        269
      2. group Id
        OG001
        value
        262
    title
    At least 1 treatment-emergent SAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        32
    title
    TEAE leading to study drug discontinuation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        35
    title
    TEAE leading to death
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        428
      2. group Id
        OG001
        value
        451
    title
    Deaths While On Treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        58
    title
    Deaths During 30 Days Post Last Dose
denoms
  1. counts
    1. group Id
      OG000
      value
      627
    2. group Id
      OG001
      value
      618
    units
    Participants
description
Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (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
    On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    OG000
    title
    Ramucirumab and Docetaxel
  2. description
    On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    OG001
    title
    Placebo and Docetaxel
param Type
NUMBER
population Description
Safety population: Randomized participants who received any quantity of study drug, grouped by the treatment they actually received.
reporting Status
POSTED
time Frame
First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)
title
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died
type
OTHER_PRE_SPECIFIED
unit Of Measure
participants

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Preserved source evidence · Not medical advice