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NCT00422656 · OUTCOME

Treatment-Related Grade 3-4 Adverse Event Rate

Perifosine in Patients With Relapsed/Refractory Waldenstrom's Macroglobulinemia · Source last updated 2017-12-26

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
90% Confidence Interval
Time frame
Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).

What was measured

The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.

Analysis population: The analysis dataset is comprised of all enrolled patients.

Groups in this outcome

Perifosine

Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.

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

Analysis denominator · Participants

GroupSource count
Perifosine37

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Perifosine35Not reported2250Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        50
        value
        35
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
The percentage of patients experiencing treatment-related grade 3-4 adverse events based on CTCAEv3 as reported on case report forms.
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients receive oral perifosine (150 mg) daily each cycle. Cycle duration is 28 days. After cycle 2, response is assessed and patients with stable or responding disease can continue for another 4 cycles or until disease progression (PD). Protocol treatment duration is 6 cycles but patients may receive perifosine maintenance per investigator discretion in absence of PD.
    id
    OG000
    title
    Perifosine
param Type
NUMBER
population Description
The analysis dataset is comprised of all enrolled patients.
reporting Status
POSTED
time Frame
Adverse events were collected every cycle on treatment.The median treatment duration was 5.6 months (range, 1.8-21.5+).
title
Treatment-Related Grade 3-4 Adverse Event Rate
type
SECONDARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice