Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01553149 · OUTCOME

Number of Patients With Toxic Events After 2 Dose Reductions

Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma · Source last updated 2025-01-07

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
While receiving protocol therapy up to 3 years after study enrollment

What was measured

Number of patients who have an additional significant toxicity coded using Common Terminology Criteria for Adverse Events Version 5.0 after experiencing two dose reductions from their assigned treatment dose.

Analysis population: Only eligible patients are considered in the analysis of this outcome measure

Groups in this outcome

Arm I (Low-dose Lenalidomide)

Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

Arm II (High-dose Lenalidomide)

Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Low-dose Lenalidomide)37
Arm II (High-dose Lenalidomide)37

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Low-dose Lenalidomide)2Not reportedNot reportedNot reportedNot reported
Arm II (High-dose Lenalidomide)16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      37
    units
    Participants
description
Number of patients who have an additional significant toxicity coded using Common Terminology Criteria for Adverse Events Version 5.0 after experiencing two dose reductions from their assigned treatment dose.
groups
  1. description
    Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    OG000
    title
    Arm I (Low-dose Lenalidomide)
  2. description
    Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    OG001
    title
    Arm II (High-dose Lenalidomide)
param Type
COUNT_OF_PARTICIPANTS
population Description
Only eligible patients are considered in the analysis of this outcome measure
reporting Status
POSTED
time Frame
While receiving protocol therapy up to 3 years after study enrollment
title
Number of Patients With Toxic Events After 2 Dose Reductions
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice