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NCT01273766 · ADVERSE EVENTS

Adverse events

Deferasirox in Treating Iron Overload Caused By Blood Transfusions in Patients With Hematologic Malignancies · Source last updated 2018-09-07

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
6 months
Other-event reporting threshold
5%

only patients on Arm I (recieving drug on protocol) were tracked for toxicities

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I

Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. deferasirox : Given orally laboratory biomarker analysis : Correlative studies enzyme-linked immunosorbent assay : Correlative studies

4 / 44 / 4Not reported / Not reported
Control Arm

blood tested on healthy patients

0 / 00 / 0Not reported / Not reported
Correlative

treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis

0 / 00 / 0Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Control Arm · EG002: Correlative

Serious 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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hyperglycemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hypokalemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    serum glutamic pyruvic transaminase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Thrombosis/thrombus/embolism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Heartburn/dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Confusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    "Distension bloating, abdominal"
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Infection Bladder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cystitis

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Gastrointestinal - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alkaline phosphatase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Proteinuria
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Taste alteration
Complete source fields
description
only patients on Arm I (recieving drug on protocol) were tracked for toxicities
event Groups
  1. description
    Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity. deferasirox : Given orally laboratory biomarker analysis : Correlative studies enzyme-linked immunosorbent assay : Correlative studies
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    Arm I
  2. description
    blood tested on healthy patients
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Control Arm
  3. description
    treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Correlative
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Low WBC
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    low Platelets
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      4
      num Events
      15
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Low Hemoglobin
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Gastrointestinal - Other
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      4
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Alkaline phosphatase
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Creatinine
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Proteinuria
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Taste alteration
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      4
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hyperglycemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    hypokalemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    serum glutamic pyruvic transaminase
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Thrombosis/thrombus/embolism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Heartburn/dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Confusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    "Distension bloating, abdominal"
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Infection Bladder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      0
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      0
      num Events
      0
    term
    Cystitis
time Frame
6 months

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Preserved source evidence · Not medical advice