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NCT01140347 · OUTCOME

Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)

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), and end of treatment (up to 34 months)

What was measured

The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).

Analysis population: Randomized participants who had FHSI-8 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) + BSC169
Placebo + BSC199

Reported measurements

Cycle 4 (n=166, 147)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-1.263.164Not reportedNot reportedNot reported
Placebo + BSC-0.814.623Not reportedNot reportedNot reported
Cycle 10 (n=70, 45)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-1.283.989Not reportedNot reportedNot reported
Placebo + BSC-0.014.378Not reportedNot reportedNot reported
Cycle 16 (n=47, 24)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-0.974.095Not reportedNot reportedNot reported
Placebo + BSC0.753.768Not reportedNot reportedNot reported
End of Treatment (n=169, 199)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab (IMC-1121B) + BSC-2.445.561Not reportedNot reportedNot reported
Placebo + BSC-2.865.618Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.164
        value
        -1.26
      2. group Id
        OG001
        spread
        4.623
        value
        -0.81
    title
    Cycle 4 (n=166, 147)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.989
        value
        -1.28
      2. group Id
        OG001
        spread
        4.378
        value
        -0.01
    title
    Cycle 10 (n=70, 45)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.095
        value
        -0.97
      2. group Id
        OG001
        spread
        3.768
        value
        0.75
    title
    Cycle 16 (n=47, 24)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.561
        value
        -2.44
      2. group Id
        OG001
        spread
        5.618
        value
        -2.86
    title
    End of Treatment (n=169, 199)
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. group Id
      OG001
      value
      199
    units
    Participants
description
The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).
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 FHSI-8 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), and end of treatment (up to 34 months)
title
Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice