Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01730937 · OUTCOME

Number of Participants by Highest Grade Adverse Event Reported

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer · Source last updated 2026-01-28

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.

What was measured

Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

Analysis population: Eligible, started treatment, and were assessed for adverse events.

Groups in this outcome

Sorafenib Alone

400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

SBRT Followed by Sorafenib

27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.

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 Alone88
SBRT Followed by Sorafenib83

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib Alone2Not reportedNot reportedNot reportedNot reported
SBRT Followed by Sorafenib1Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib Alone21Not reportedNot reportedNot reportedNot reported
SBRT Followed by Sorafenib20Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib Alone49Not reportedNot reportedNot reportedNot reported
SBRT Followed by Sorafenib51Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib Alone10Not reportedNot reportedNot reportedNot reported
SBRT Followed by Sorafenib9Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sorafenib Alone6Not reportedNot reportedNot reportedNot reported
SBRT Followed by Sorafenib2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        20
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        51
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      88
    2. group Id
      OG001
      value
      83
    units
    Participants
description
Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
groups
  1. description
    400 mg sorafenib by mouth twice a day for 28-day cycle. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Sorafenib Alone
  2. description
    27.5 Gy to 50 Gy stereotactic body radiation therapy (SBRT) in 5 fractions 24-72 hours apart over 5-15 days followed within 1-5 days by one cycle of 200 mg sorafenib by mouth twice a day. Starting with second cycle, if tolerable, increase to 400 mg sorafenib by mouth twice a day. Continue up to 5 years in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    SBRT Followed by Sorafenib
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible, started treatment, and were assessed for adverse events.
reporting Status
POSTED
time Frame
From randomization to last follow-up: weekly during SBRT, post-SBRT/pre-sorafenib, monthly during sorafenib, and overall, from study entry: every 3 months for 2 years, then every 6 months. Maximum follow-up at time of analysis was 7.6 years.
title
Number of Participants by Highest Grade Adverse Event Reported
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice