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NCT00561418 · ADVERSE EVENTS

Adverse events

Vorinostat After Stem Cell Transplant in Treating Patients With High-Risk Lymphoma · Source last updated 2015-07-16

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
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vorinostat (SAHA)

Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)

0 / 2312 / 23Not reported / Not reported

Group identifiers: EG000: Vorinostat (SAHA)

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
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        23
        num Events
        12
      term
      fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        23
        num Events
        11
      term
      Lymphopenia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        23
        num Events
        11
      term
      Thrombocytopenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        23
        num Events
        10
      term
      Leukopenia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        23
        num Events
        10
      term
      anemia
    Complete source fields
    event Groups
    1. description
      Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations. vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles. Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)
      id
      EG000
      other Num Affected
      12
      other Num At Risk
      23
      serious Num Affected
      0
      serious Num At Risk
      23
      title
      Vorinostat (SAHA)
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        12
        num At Risk
        23
        num Events
        12
      term
      fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        23
        num Events
        11
      term
      Lymphopenia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Injury, poisoning and procedural complications
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        11
        num At Risk
        23
        num Events
        11
      term
      Thrombocytopenia
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        23
        num Events
        10
      term
      Leukopenia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE version 3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        23
        num Events
        10
      term
      anemia
    time Frame
    The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was utilized for adverse event reporting.

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

    Preserved source evidence · Not medical advice