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NCT01711632 · OUTCOME

Toxicity (Safety and Tolerability)

BRAF Inhibitor, Vemurafenib, in Patients With Relapsed or Refractory Hairy Cell Leukemia · Source last updated 2025-10-20

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
2 years

What was measured

Toxicity will be graded and recorded using the NCI Common Toxicology Criteria version 4.0.

Groups in this outcome

Vemurafenib

Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days).

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

Analysis denominator · Participants

GroupSource count
Vemurafenib36

Reported measurements

Source class 1

Dose reduction to 720mg twice daily

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib2Not reportedNot reportedNot reportedNot reported

Dose reduction to 480mg twice daily

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib10Not reportedNot reportedNot reportedNot reported

Dose reduction to 240mg twice daily

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib1Not reportedNot reportedNot reportedNot reported

Did not need a dose reduction

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vemurafenib23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Dose reduction to 720mg twice daily
    2. measurements
      1. group Id
        OG000
        value
        10
      title
      Dose reduction to 480mg twice daily
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Dose reduction to 240mg twice daily
    4. measurements
      1. group Id
        OG000
        value
        23
      title
      Did not need a dose reduction
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Toxicity will be graded and recorded using the NCI Common Toxicology Criteria version 4.0.
groups
  1. description
    Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days).
    id
    OG000
    title
    Vemurafenib
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Toxicity (Safety and Tolerability)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice