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NCT02339740 · ADVERSE EVENTS

Adverse events

Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia · Source last updated 2026-02-18

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
While patients were on protocol therapy (including up to 6 courses) or during follow-up.
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Standard Risk

WBC \<10,000 cells/µL

3 / 10189 / 1011 / 101
High Risk

WBC ≥10,000 cells/µL

2 / 5750 / 570 / 57

Group identifiers: EG000: Standard Risk · EG001: High Risk

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
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Multi-organ failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infections and infestations - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Depressed level of consciousness
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Encephalopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Intracranial hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Seizure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Psychosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Bronchopulmonary hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Retinoic acid syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Hypohidrosis

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Hearing impaired
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Eye disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Papilledema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Periorbital edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Vitreous hemorrhage
Complete source fields
description
Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    101
    description
    WBC \<10,000 cells/µL
    id
    EG000
    other Num Affected
    89
    other Num At Risk
    101
    serious Num Affected
    3
    serious Num At Risk
    101
    title
    Standard Risk
  2. deaths Num Affected
    0
    deaths Num At Risk
    57
    description
    WBC ≥10,000 cells/µL
    id
    EG001
    other Num Affected
    50
    other Num At Risk
    57
    serious Num Affected
    2
    serious Num At Risk
    57
    title
    High Risk
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      57
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      57
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Left ventricular systolic dysfunction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Ventricular arrhythmia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Hearing impaired
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Eye disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Papilledema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Periorbital edema
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Vitreous hemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Multi-organ failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Infections and infestations - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Depressed level of consciousness
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Encephalopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Intracranial hemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Seizure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      101
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Psychosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Bronchopulmonary hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
      num Events
      0
    term
    Respiratory failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      57
    term
    Retinoic acid syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      101
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      57
    term
    Hypohidrosis
time Frame
While patients were on protocol therapy (including up to 6 courses) or during follow-up.

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