Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02668653 · ADVERSE EVENTS

Adverse events

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) · Source last updated 2024-08-06

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
Treatment-emergent adverse events were collected from date of first dose up to 30 days after last dose, up to 36 cycles following continuation phase (approximately 6 years 11 months, each cycle is 28 days).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Quizartinib

Safety Analysis Set includes all subjects who received at least 1 dose of quizartinib/placebo.

146 / 265258 / 265130 / 265
Placebo

Safety Analysis Set includes all subjects who received at least 1 dose of quizartinib/placebo.

124 / 268258 / 268156 / 268

Group identifiers: EG000: Quizartinib · EG001: Placebo

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      268
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      268
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      268
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      268
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Autoimmune haemolytic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      268
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Disseminated intravascular coagulation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      268
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      268
    term
    Cardiac arrest

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
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      265
      num Events
      169
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      268
      num Events
      178
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      265
      num Events
      46
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      268
      num Events
      37
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      265
      num Events
      39
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      268
      num Events
      35
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      265
      num Events
      130
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
      num Events
      29
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      265
      num Events
      22
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      268
      num Events
      17
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      265
      num Events
      146
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      268
      num Events
      133
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      265
      num Events
      168
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      268
      num Events
      141
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      265
      num Events
      88
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      268
      num Events
      76
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      265
      num Events
      70
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      268
      num Events
      66
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      265
      num Events
      59
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      268
      num Events
      52
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      265
      num Events
      77
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      268
      num Events
      91
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      265
      num Events
      37
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
      num Events
      27
    term
    Dyspepsia
Complete source fields
event Groups
  1. deaths Num Affected
    130
    deaths Num At Risk
    265
    description
    Safety Analysis Set includes all subjects who received at least 1 dose of quizartinib/placebo.
    id
    EG000
    other Num Affected
    258
    other Num At Risk
    265
    serious Num Affected
    146
    serious Num At Risk
    265
    title
    Quizartinib
  2. deaths Num Affected
    156
    deaths Num At Risk
    268
    description
    Safety Analysis Set includes all subjects who received at least 1 dose of quizartinib/placebo.
    id
    EG001
    other Num Affected
    258
    other Num At Risk
    268
    serious Num Affected
    124
    serious Num At Risk
    268
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      265
      num Events
      169
    2. group Id
      EG001
      num Affected
      97
      num At Risk
      268
      num Events
      178
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      265
      num Events
      46
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      268
      num Events
      37
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      265
      num Events
      39
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      268
      num Events
      35
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      265
      num Events
      130
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
      num Events
      29
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      265
      num Events
      22
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      268
      num Events
      17
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      97
      num At Risk
      265
      num Events
      146
    2. group Id
      EG001
      num Affected
      94
      num At Risk
      268
      num Events
      133
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      265
      num Events
      168
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      268
      num Events
      141
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      265
      num Events
      88
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      268
      num Events
      76
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      265
      num Events
      70
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      268
      num Events
      66
    term
    Stomatitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      265
      num Events
      59
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      268
      num Events
      52
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      265
      num Events
      77
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      268
      num Events
      91
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      265
      num Events
      37
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
      num Events
      27
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      268
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      268
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      268
    term
    Myelosuppression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      268
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      268
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Autoimmune haemolytic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      268
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Disseminated intravascular coagulation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      268
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      268
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      265
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      268
    term
    Cardiac arrest
time Frame
Treatment-emergent adverse events were collected from date of first dose up to 30 days after last dose, up to 36 cycles following continuation phase (approximately 6 years 11 months, each cycle is 28 days).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice