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NCT05184842 · ADVERSE EVENTS

Adverse events

Metabolically Optimized, Non-cytotoxic Low Dose Weekly Decitabine/Venetoclax in MDS and AML · Source last updated 2026-01-05

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
All adverse events that occur on or after day 1 of cycle 1 through 30 days after the final dose of study drug (end of treatment) will be reported, up to approximately 24 months total.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Decitabine/Venetoclax (Single Arm)

Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 28 of each cycle (28day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)

0 / 3128 / 314 / 31

Group identifiers: EG000: Decitabine/Venetoclax (Single Arm)

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
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        31
      term
      Nausea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Vomiting
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Diarrhea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        31
      term
      Fatigue
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        31
      term
      Dizziness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Verbatim Tem
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Weakness
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Dyspnea
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Acute Kidney Injury
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        31
      term
      Cough
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Sore Throat
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Dysphagia
    Complete source fields
    event Groups
    1. deaths Num Affected
      4
      deaths Num At Risk
      31
      description
      Administration: Decitabine is reconstituted with 5 ml sterile water to facilitate subcutaneous administration. Decitabine is given by subcutaneous injection. Venetoclax is taken as a tablet prepared by patients pharmacy. Venetoclax is given at a dose of 400 mg po once per week concurrently with the Decitabine dose (+/- 1 day allowed ). Venetoclax: Venetoclax 400 mg po on days 1, 8, 15 and 28 of each cycle (28day cycle) Decitabine: Decitabine 0.2 mg/kg SQ (subcutaneous) on days 2, 9, 16, 23 (for aggressive disease will add decitabine on days 3, 10, 17, 24)
      id
      EG000
      other Num Affected
      28
      other Num At Risk
      31
      serious Num Affected
      0
      serious Num At Risk
      31
      title
      Decitabine/Venetoclax (Single Arm)
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        31
      term
      Nausea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Vomiting
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Diarrhea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Constipation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        13
        num At Risk
        31
      term
      Fatigue
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        31
      term
      Dizziness
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Verbatim Tem
      organ System
      General disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Weakness
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        31
      term
      Dyspnea
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Acute Kidney Injury
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        7
        num At Risk
        31
      term
      Cough
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Sore Throat
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (5.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        31
      term
      Dysphagia
    time Frame
    All adverse events that occur on or after day 1 of cycle 1 through 30 days after the final dose of study drug (end of treatment) will be reported, up to approximately 24 months total.

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

    Preserved source evidence · Not medical advice