Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01348607 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
1 month
Other-event reporting threshold
0%

Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I - Methylphenidate Hydrochloride

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

0 / 11 / 1Not reported / Not reported
Arm II -Modafinil

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

0 / 00 / 0Not reported / Not reported
Arm III Placebo

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

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Arm I - Methylphenidate Hydrochloride · EG001: Arm II -Modafinil · EG002: Arm III Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      decreased appetite
    Complete source fields
    description
    Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.
    event Groups
    1. description
      Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Arm I - Methylphenidate Hydrochloride
    2. description
      Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Arm II -Modafinil
    3. description
      Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      0
      serious Num Affected
      0
      serious Num At Risk
      0
      title
      Arm III Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        0
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        0
        num Events
        0
      term
      decreased appetite
    time Frame
    1 month

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

    Preserved source evidence · Not medical advice