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NCT01536392 · ADVERSE EVENTS

Adverse events

Oral Ondansetron Versus Transdermal Granisetron (Sancuso) for Women With Cervical, Endometrial or Vaginal Cancer Receiving Pelvic Chemoradiation · Source last updated 2021-06-11

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
Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks
Other-event reporting threshold
3%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1: Transdermal Granisetron

8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.

0 / 4115 / 410 / 41
Arm 2: Oral Ondansetron

8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.

0 / 3412 / 340 / 34

Group identifiers: EG000: Arm 1: Transdermal Granisetron · EG001: Arm 2: Oral Ondansetron

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
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        34
      term
      Constipation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        34
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        15
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        12
        num At Risk
        34
      term
      Nausea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        34
      term
      Fatigue
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      41
      description
      8 mg ondansetron given IV prior to Cycle 1 of Cisplatin then 34.3 mg granisetron patch applied and then reapplied every 7 days prior to Cycles 2-5 of Cisplatin.
      id
      EG000
      other Num Affected
      15
      other Num At Risk
      41
      serious Num Affected
      0
      serious Num At Risk
      41
      title
      Arm 1: Transdermal Granisetron
    2. deaths Num Affected
      0
      deaths Num At Risk
      34
      description
      8 mg ondansetron given IV prior to Cycles 1-5 then 8 mg oral ondansetron every 8 hours for 72 hours following each Cisplatin and PRN in-between cycles.
      id
      EG001
      other Num Affected
      12
      other Num At Risk
      34
      serious Num Affected
      0
      serious Num At Risk
      34
      title
      Arm 2: Oral Ondansetron
    frequency Threshold
    3
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        8
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        6
        num At Risk
        34
      term
      Constipation
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        9
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        34
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        15
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        12
        num At Risk
        34
      term
      Nausea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        41
      2. group Id
        EG001
        num Affected
        10
        num At Risk
        34
      term
      Fatigue
    time Frame
    Baseline through 7 days for each chemotherapy cycle, an average of 6 weeks

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

    Preserved source evidence · Not medical advice