Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00105443 · OUTCOME

Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2014-10-31

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
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

What was measured

PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.

Analysis population: In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006

Groups in this outcome

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.

Placebo

Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

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

Analysis denominator · Participants

GroupSource count
Sorafenib (Nexavar, BAY43-9006)174
Placebo178

Reported measurements

Cycle 3 day 1 change <8 points
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)151Not reportedNot reportedNot reportedNot reported
Placebo139Not reportedNot reportedNot reportedNot reported
Cycle 3 day 1 change ≥8 points
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib (Nexavar, BAY43-9006)23Not reportedNot reportedNot reportedNot reported
Placebo39Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        139
    title
    Cycle 3 day 1 change <8 points
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        39
    title
    Cycle 3 day 1 change ≥8 points
denoms
  1. counts
    1. group Id
      OG000
      value
      174
    2. group Id
      OG001
      value
      178
    units
    Participants
description
PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
groups
  1. description
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    id
    OG000
    title
    Sorafenib (Nexavar, BAY43-9006)
  2. description
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006
reporting Status
POSTED
time Frame
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
title
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice