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NCT01254890 · ADVERSE EVENTS

Adverse events

Sorafenib and 5-Azacitidine in Acute Leukemia + Myelodysplastic Syndrome · Source last updated 2016-05-06

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
Adverse events were collected from the time of informed consent to discontinuation of treatment, up to 1 year. Total study period was 3 years and 11 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I: Azacitidine + Sorafenib

Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.

0 / 33 / 3Not reported / Not reported
Phase II: Azacitidine + Sorafenib

Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.

0 / 5751 / 57Not reported / Not reported

Group identifiers: EG000: Phase I: Azacitidine + Sorafenib · EG001: Phase II: Azacitidine + Sorafenib

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
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        19
        num At Risk
        57
        num Events
        20
      term
      Alanine Aminotransferase
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        22
        num At Risk
        57
        num Events
        22
      term
      Aspartate Aminotransferase
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        3
        num Events
        3
      2. group Id
        EG001
        num Affected
        28
        num At Risk
        57
        num Events
        28
      term
      Bilirubin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        15
        num At Risk
        57
        num Events
        15
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        25
        num At Risk
        57
        num Events
        25
      term
      Fatigue
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Atelectasis
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Confusion
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Dysphagia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        7
        num At Risk
        57
        num Events
        7
      term
      Dyspnea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Hypertension
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Hyperuricemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Irritability
    Complete source fields
    event Groups
    1. description
      Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
      id
      EG000
      other Num Affected
      3
      other Num At Risk
      3
      serious Num Affected
      0
      serious Num At Risk
      3
      title
      Phase I: Azacitidine + Sorafenib
    2. description
      Azacitidine (AZA) 75 mg/m\^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
      id
      EG001
      other Num Affected
      51
      other Num At Risk
      57
      serious Num Affected
      0
      serious Num At Risk
      57
      title
      Phase II: Azacitidine + Sorafenib
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        19
        num At Risk
        57
        num Events
        20
      term
      Alanine Aminotransferase
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        22
        num At Risk
        57
        num Events
        22
      term
      Aspartate Aminotransferase
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        3
        num Events
        3
      2. group Id
        EG001
        num Affected
        28
        num At Risk
        57
        num Events
        28
      term
      Bilirubin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        15
        num At Risk
        57
        num Events
        15
      term
      Diarrhea
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        3
        num Events
        2
      2. group Id
        EG001
        num Affected
        25
        num At Risk
        57
        num Events
        25
      term
      Fatigue
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Atelectasis
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Confusion
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Dysphagia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        7
        num At Risk
        57
        num Events
        7
      term
      Dyspnea
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Hypertension
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Hyperuricemia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        3
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        57
        num Events
        0
      term
      Irritability
    time Frame
    Adverse events were collected from the time of informed consent to discontinuation of treatment, up to 1 year. Total study period was 3 years and 11 months.

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

    Preserved source evidence · Not medical advice