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NCT00949117 · ADVERSE EVENTS

Adverse events

Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer · Source last updated 2014-04-02

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
24 weeks
Other-event reporting threshold
0%

Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.

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

Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

0 / 41 / 4Not reported / Not reported
Arm II Cyproheptadine HCl and PediaSure or Ensure

Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.

0 / 52 / 5Not reported / Not reported

Group identifiers: EG000: Arm I- Cyproheptadine Hydrochloride · EG001: Arm II Cyproheptadine HCl and PediaSure or Ensure

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
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
        num Events
        0
      term
      somnolence
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      relapse of cancer
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      rash
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      flatulence
    Complete source fields
    description
    Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.
    event Groups
    1. description
      Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm I- Cyproheptadine Hydrochloride
    2. description
      Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
      id
      EG001
      other Num Affected
      2
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      Arm II Cyproheptadine HCl and PediaSure or Ensure
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
        num Events
        0
      term
      somnolence
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      relapse of cancer
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      rash
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        4
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        5
        num Events
        1
      term
      flatulence
    time Frame
    24 weeks

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

    Preserved source evidence · Not medical advice