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NCT03836209 · ADVERSE EVENTS

Adverse events

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia · Source last updated 2026-07-23

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 (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.
Other-event reporting threshold
5%

A serious adverse event (SAE) is any untoward medical occurrence after study treatment initiation that results in death, is life-threatening, requires or prolongs hospitalization, causes disability/incapacity, is a congenital anomaly, or, based on medical judgment, may jeopardize the patient or require intervention to prevent serious outcomes.

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

Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles

48 / 9083 / 9023 / 90
Arm B

Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles

39 / 8781 / 8727 / 87

Group identifiers: EG000: Arm A · EG001: Arm B

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
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Bacterial sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bronchopulmonary aspergillosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Confusional state
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Drug-induced liver injury

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
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      90
      num Events
      28
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      87
      num Events
      36
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      90
      num Events
      158
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      87
      num Events
      168
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      90
      num Events
      24
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      87
      num Events
      28
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      90
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      87
      num Events
      5
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      90
      num Events
      23
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      87
      num Events
      13
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      90
      num Events
      22
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      87
      num Events
      13
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      90
      num Events
      44
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      87
      num Events
      34
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      90
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      87
      num Events
      9
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      90
      num Events
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      87
      num Events
      20
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      90
      num Events
      65
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      87
      num Events
      58
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      90
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      87
      num Events
      11
    term
    Hypocalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      90
      num Events
      33
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      87
      num Events
      61
    term
    Hypokalaemia
Complete source fields
description
A serious adverse event (SAE) is any untoward medical occurrence after study treatment initiation that results in death, is life-threatening, requires or prolongs hospitalization, causes disability/incapacity, is a congenital anomaly, or, based on medical judgment, may jeopardize the patient or require intervention to prevent serious outcomes.
event Groups
  1. deaths Num Affected
    23
    deaths Num At Risk
    90
    description
    Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
    id
    EG000
    other Num Affected
    83
    other Num At Risk
    90
    serious Num Affected
    48
    serious Num At Risk
    90
    title
    Arm A
  2. deaths Num Affected
    27
    deaths Num At Risk
    87
    description
    Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
    id
    EG001
    other Num Affected
    81
    other Num At Risk
    87
    serious Num Affected
    39
    serious Num At Risk
    87
    title
    Arm B
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      90
      num Events
      28
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      87
      num Events
      36
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      90
      num Events
      158
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      87
      num Events
      168
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      90
      num Events
      24
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      87
      num Events
      28
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      90
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      87
      num Events
      5
    term
    Colitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      90
      num Events
      23
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      87
      num Events
      13
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      90
      num Events
      22
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      87
      num Events
      13
    term
    Decreased appetite
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      90
      num Events
      44
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      87
      num Events
      34
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      90
      num Events
      19
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      87
      num Events
      9
    term
    Epistaxis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      90
      num Events
      23
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      87
      num Events
      20
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      90
      num Events
      65
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      87
      num Events
      58
    term
    Febrile neutropenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      90
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      87
      num Events
      11
    term
    Hypocalcaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      90
      num Events
      33
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      87
      num Events
      61
    term
    Hypokalaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Abdominal pain upper
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Appendicitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Bacterial sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      90
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Bronchopulmonary aspergillosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      90
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      87
      num Events
      0
    term
    Confusional state
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE V 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      90
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      87
      num Events
      1
    term
    Drug-induced liver injury
time Frame
Adverse events (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.

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Preserved source evidence · Not medical advice