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NCT03038308 · ADVERSE EVENTS

Adverse events

Treatment of Hyperprolactinemia With the Non-ergoline Dopamine Agonist Ropinirole · Source last updated 2024-06-04

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
6 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ROP Intervention

Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole

0 / 108 / 100 / 10

Group identifiers: EG000: ROP Intervention

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
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        10
      term
      Fatigue
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        10
      term
      Nausea
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
      term
      Headache
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      10
      description
      Patients with hyperprolactinemia were treated with long-term ROP therapy for 6 months in an open-label dose escalation study Ropinirole: 0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
      id
      EG000
      other Num Affected
      8
      other Num At Risk
      10
      serious Num Affected
      0
      serious Num At Risk
      10
      title
      ROP Intervention
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        6
        num At Risk
        10
      term
      Fatigue
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        10
      term
      Nausea
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        10
      term
      Headache
    time Frame
    6 months

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

    Preserved source evidence · Not medical advice