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NCT01132547 · ADVERSE EVENTS

Adverse events

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer · Source last updated 2015-07-02

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I Cyproheptadine Hydrochloride

Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks. cyproheptadine hydrochloride: Given orally

3 / 94 / 9Not reported / Not reported
Arm II Placebo

Patients receive an oral placebo twice daily for 8 weeks. placebo: Given orally

0 / 134 / 13Not reported / Not reported

Group identifiers: EG000: Arm I Cyproheptadine Hydrochloride · EG001: Arm II Placebo

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Intracranial hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Platelet count decrease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutrophil count decrease

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pain in extremity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Skin and Subcutaneous tissue disorders other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Allergic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Somnolence
Complete source fields
event Groups
  1. description
    Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks. cyproheptadine hydrochloride: Given orally
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Arm I Cyproheptadine Hydrochloride
  2. description
    Patients receive an oral placebo twice daily for 8 weeks. placebo: Given orally
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    13
    serious Num Affected
    0
    serious Num At Risk
    13
    title
    Arm II Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pain in extremity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Skin and Subcutaneous tissue disorders other
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Allergic reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      9
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Somnolence
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Intracranial hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Platelet count decrease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutrophil count decrease

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Preserved source evidence · Not medical advice