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NCT02421939 · ADVERSE EVENTS

Adverse events

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation · Source last updated 2025-12-04

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
Adverse events: From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days) All cause mortality: From randomization up to end of study (approximately 112 months)
Other-event reporting threshold
5%

Adverse events: The SAF consisted of all participants who received at least dose of study treatment (gilteritinib or salvage chemotherapy). All cause mortality: All randomised participants.

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

Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.

211 / 246242 / 246204 / 247
Salvage Chemotherapy

Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).

34 / 109103 / 10996 / 124

Group identifiers: EG000: Gilteritinib · EG001: Salvage Chemotherapy

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 v23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      246
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Aplasia pure red cell
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Bone marrow failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      246
      num Events
      113
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      109
      num Events
      15
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Haemolytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Acute coronary syndrome

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 v23
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      246
      num Events
      493
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      109
      num Events
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      246
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      246
      num Events
      73
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      109
      num Events
      37
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      246
      num Events
      115
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      109
      num Events
      18
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      246
      num Events
      301
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      109
      num Events
      41
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      3
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      246
      num Events
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    term
    Retinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
      num Events
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      246
      num Events
      44
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      109
      num Events
      17
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      5
    term
    Abdominal pain upper
Complete source fields
description
Adverse events: The SAF consisted of all participants who received at least dose of study treatment (gilteritinib or salvage chemotherapy). All cause mortality: All randomised participants.
event Groups
  1. deaths Num Affected
    204
    deaths Num At Risk
    247
    description
    Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
    id
    EG000
    other Num Affected
    242
    other Num At Risk
    246
    serious Num Affected
    211
    serious Num At Risk
    246
    title
    Gilteritinib
  2. deaths Num Affected
    96
    deaths Num At Risk
    124
    description
    Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
    id
    EG001
    other Num Affected
    103
    other Num At Risk
    109
    serious Num Affected
    34
    serious Num At Risk
    109
    title
    Salvage Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      246
      num Events
      493
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      109
      num Events
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      246
      num Events
      9
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      109
      num Events
      6
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      246
      num Events
      73
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      109
      num Events
      37
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      246
      num Events
      115
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      109
      num Events
      18
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      246
      num Events
      301
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      109
      num Events
      41
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      15
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      3
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      14
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      109
      num Events
      7
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      246
      num Events
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    term
    Dry eye
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
      num Events
      23
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    term
    Retinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      246
      num Events
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Vision blurred
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      246
      num Events
      44
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      109
      num Events
      17
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      246
      num Events
      18
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      5
    term
    Abdominal pain upper
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      246
      num Events
      11
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Aplasia pure red cell
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Bone marrow failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      246
      num Events
      113
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      109
      num Events
      15
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Haemolytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      246
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Leukocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      246
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v23
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      246
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    term
    Acute coronary syndrome
time Frame
Adverse events: From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days) All cause mortality: From randomization up to end of study (approximately 112 months)

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Preserved source evidence · Not medical advice