Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01140347 · OUTCOME

Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib · Source last updated 2015-12-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)

What was measured

The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.

Analysis population: Randomized participants who had an EQ-5D score at baseline and the specified time points.

Groups in this outcome

Ramucirumab (IMC-1121B) + BSC

Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

Placebo + BSC

Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.

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-1121B) + BSC166
Placebo + BSC190

Reported measurements

Cycle 4 (n=166, 145)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-0.0380.189Not reportedNot reportedNot reported
Placebo + BSC-0.0460.245Not reportedNot reportedNot reported
Cycle 10 (n=71, 45)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-0.0540.212Not reportedNot reportedNot reported
Placebo + BSC0.0030.148Not reportedNot reportedNot reported
Cycle 16 (n=47, 25)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-0.0620.214Not reportedNot reportedNot reported
Placebo + BSC-0.0120.085Not reportedNot reportedNot reported
End of Treatment (n=166, 190)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-0.1290.290Not reportedNot reportedNot reported
Placebo + BSC-0.1440.280Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.189
        value
        -0.038
      2. group Id
        OG001
        spread
        0.245
        value
        -0.046
    title
    Cycle 4 (n=166, 145)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.212
        value
        -0.054
      2. group Id
        OG001
        spread
        0.148
        value
        0.003
    title
    Cycle 10 (n=71, 45)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.214
        value
        -0.062
      2. group Id
        OG001
        spread
        0.085
        value
        -0.012
    title
    Cycle 16 (n=47, 25)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.290
        value
        -0.129
      2. group Id
        OG001
        spread
        0.280
        value
        -0.144
    title
    End of Treatment (n=166, 190)
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      190
    units
    Participants
description
The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.
dispersion Type
Standard Deviation
groups
  1. description
    Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    OG000
    title
    Ramucirumab (IMC-1121B) + BSC
  2. description
    Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
    id
    OG001
    title
    Placebo + BSC
param Type
MEAN
population Description
Randomized participants who had an EQ-5D score at baseline and the specified time points.
reporting Status
POSTED
time Frame
Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)
title
Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice