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NCT01348607 · OUTCOME

Adverse Events

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy · Source last updated 2014-02-21

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

Measure
NUMBER
Unit
events
Interval / dispersion
Not reported
Time frame
29 days

What was measured

Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.

Groups in this outcome

Arm I - Methylphenidate Hydrochloride

Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.

Arm II -Modafinil

Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.

Arm III Placebo

Patients receive oral placebo once daily for 7-42 days in the absence of 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
Arm I - Methylphenidate Hydrochloride1
Arm II -Modafinil0
Arm III Placebo0

Reported measurements

Source class 1
Values in events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I - Methylphenidate Hydrochloride1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.
groups
  1. description
    Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
    id
    OG000
    title
    Arm I - Methylphenidate Hydrochloride
  2. description
    Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
    id
    OG001
    title
    Arm II -Modafinil
  3. description
    Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
    id
    OG002
    title
    Arm III Placebo
param Type
NUMBER
reporting Status
POSTED
time Frame
29 days
title
Adverse Events
type
SECONDARY
unit Of Measure
events

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

Preserved source evidence · Not medical advice