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NCT00071799 · ADVERSE EVENTS

Adverse events

A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care · Source last updated 2019-10-29

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 AEs for the 'core study' from Day 1 to 42 months.
Other-event reporting threshold
5%

Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.

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

Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.

114 / 175175 / 175Not reported / Not reported
Best Supportive Care Only

Care can include transfusions, antibiotics, myeloid growth factors \[G-CSF and GM CSF\] for neutropenic infections until the end of the study.

71 / 10286 / 102Not reported / Not reported
Low-dose Cytarabine

Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.

27 / 4444 / 44Not reported / Not reported
Standard Chemotherapy

Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.

14 / 1919 / 19Not reported / Not reported

Group identifiers: EG000: Azacitidine · EG001: Best Supportive Care Only · EG002: Low-dose Cytarabine · EG003: Standard 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 10.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Haemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Haemorrhagic diathesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Leukocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Acute myocardial infarction

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 10.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      19
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      19
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      19
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      19
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      19
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      19
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bundle branch block right
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Cardiomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Sinus bradycardia
Complete source fields
description
Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.
event Groups
  1. description
    Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
    id
    EG000
    other Num Affected
    175
    other Num At Risk
    175
    serious Num Affected
    114
    serious Num At Risk
    175
    title
    Azacitidine
  2. description
    Care can include transfusions, antibiotics, myeloid growth factors \[G-CSF and GM CSF\] for neutropenic infections until the end of the study.
    id
    EG001
    other Num Affected
    86
    other Num At Risk
    102
    serious Num Affected
    71
    serious Num At Risk
    102
    title
    Best Supportive Care Only
  3. description
    Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
    id
    EG002
    other Num Affected
    44
    other Num At Risk
    44
    serious Num Affected
    27
    serious Num At Risk
    44
    title
    Low-dose Cytarabine
  4. description
    Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
    id
    EG003
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    14
    serious Num At Risk
    19
    title
    Standard Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      19
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      19
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      19
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Lymphadenopathy
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      19
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      19
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      19
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bradycardia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bundle branch block right
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Cardiomegaly
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Sinus bradycardia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      19
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Haemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Haemorrhagic diathesis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Leukocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      19
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 10.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      175
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      102
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      44
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      19
    term
    Acute myocardial infarction
time Frame
Treatment-emergent AEs for the 'core study' from Day 1 to 42 months.

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Preserved source evidence · Not medical advice