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NCT02939287 · ADVERSE EVENTS

Adverse events

Aprepitant- and Olanzapine- Containing Anti-emetic Regimens With High Dose Melphalan · Source last updated 2024-10-22

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
Patients were monitored for 3 years.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Aprepitant

aprepitant plus standard anti-emetic regimen Aprepitant: Add aprepitant to anti-emetic regimen

3 / 140 / 140 / 14
Olanzapine

olanzapine plus standard anti-emetic regimen Olanzapine: add olanzapine to anti-emetic regimen

3 / 210 / 2121 / 21
Aprepitant Plus Olanzapine

aprepitant and olanzapine plus standard anti-emetic regimen Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen

1 / 80 / 80 / 8

Group identifiers: EG000: Aprepitant · EG001: Olanzapine · EG002: Aprepitant Plus Olanzapine

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
    Gastrointestinal disorders
    source Vocabulary
    mucositis
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      21
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      8
    term
    Mucositis

Other reported adverse events

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

    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      14
      description
      aprepitant plus standard anti-emetic regimen Aprepitant: Add aprepitant to anti-emetic regimen
      id
      EG000
      other Num Affected
      0
      other Num At Risk
      14
      serious Num Affected
      3
      serious Num At Risk
      14
      title
      Aprepitant
    2. deaths Num Affected
      21
      deaths Num At Risk
      21
      description
      olanzapine plus standard anti-emetic regimen Olanzapine: add olanzapine to anti-emetic regimen
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      21
      serious Num Affected
      3
      serious Num At Risk
      21
      title
      Olanzapine
    3. deaths Num Affected
      0
      deaths Num At Risk
      8
      description
      aprepitant and olanzapine plus standard anti-emetic regimen Aprepitant plus Olanzapine: add aprepitant and olanzapine to anti-emetic regimen
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      8
      serious Num Affected
      1
      serious Num At Risk
      8
      title
      Aprepitant Plus Olanzapine
    frequency Threshold
    5
    serious Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      mucositis
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        14
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        21
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        8
      term
      Mucositis
    time Frame
    Patients were monitored for 3 years.

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

    Preserved source evidence · Not medical advice