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NCT01159067 · ADVERSE EVENTS

Adverse events

Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload · Source last updated 2019-06-18

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
From Cycle 1 to Cycle 6
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.

0 / 11 / 10 / 1

Group identifiers: EG000: Arm I

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
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Iron overload
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Neutrophils/granulocytes (ANC/AGC)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        10
      term
      Platelets
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Hypotension
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fatigue (asthenia, lethargy, malaise)
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fever
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Rigors/chills
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Hypopigmentation
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Ulceration
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Anorexia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Nausea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Vomiting
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      Patients receive oral deferasirox once daily for up to 6 months in the absence of unacceptable toxicity.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      Arm I
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Iron overload
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        2
      term
      Neutrophils/granulocytes (ANC/AGC)
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        10
      term
      Platelets
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Hypotension
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fatigue (asthenia, lethargy, malaise)
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      notes
      Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Fever
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Rigors/chills
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Hypopigmentation
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Ulceration
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Anorexia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        6
      term
      Nausea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
        num Events
        1
      term
      Vomiting
    time Frame
    From Cycle 1 to Cycle 6

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

    Preserved source evidence · Not medical advice