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NCT01074047 · ADVERSE EVENTS

Adverse events

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29

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
From first dose to 1) last dose + 28 days for azacitidine and low-dose cytarabine; 2) last dose + 70 days for intensive chemotherapy; 3) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively
Other-event reporting threshold
5%

3\) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively. AEs reported for the Azacitidine group are those that occurred in the treatment phase, AEs reported in the Azacitidine extension group occurred during extension phase

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

Azacitidine 75 mg/m\^2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion

188 / 236226 / 236Not reported / Not reported
BSC Only

Transfusion of blood products, antibiotics, antifungals and nutritional help

30 / 4033 / 40Not reported / Not reported
Low-dose Cytarabine

Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC

118 / 153151 / 153Not reported / Not reported
Intensive Chemotherapy

Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed

27 / 4242 / 42Not reported / Not reported
Azacitidine-extension

Azacitidine 75 mg/m\^2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.

10 / 2218 / 22Not reported / Not reported

Group identifiers: EG000: Azacitidine · EG001: BSC Only · EG002: Low-dose Cytarabine · EG003: Intensive Chemotherapy · EG004: Azacitidine-extension

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LYMPHADENOPATHY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    NEUTROPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    PANCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    THROMBOCYTOPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    THROMBOTIC THROMBOCYTOPENIC PURPURA

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      22
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOCYTOSIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      22
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      22
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    ABDOMINAL DISTENSION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    CONSTIPATION
Complete source fields
description
3\) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively. AEs reported for the Azacitidine group are those that occurred in the treatment phase, AEs reported in the Azacitidine extension group occurred during extension phase
event Groups
  1. description
    Azacitidine 75 mg/m\^2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion
    id
    EG000
    other Num Affected
    226
    other Num At Risk
    236
    serious Num Affected
    188
    serious Num At Risk
    236
    title
    Azacitidine
  2. description
    Transfusion of blood products, antibiotics, antifungals and nutritional help
    id
    EG001
    other Num Affected
    33
    other Num At Risk
    40
    serious Num Affected
    30
    serious Num At Risk
    40
    title
    BSC Only
  3. description
    Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC
    id
    EG002
    other Num Affected
    151
    other Num At Risk
    153
    serious Num Affected
    118
    serious Num At Risk
    153
    title
    Low-dose Cytarabine
  4. description
    Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed
    id
    EG003
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    27
    serious Num At Risk
    42
    title
    Intensive Chemotherapy
  5. description
    Azacitidine 75 mg/m\^2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    EG004
    other Num Affected
    18
    other Num At Risk
    22
    serious Num Affected
    10
    serious Num At Risk
    22
    title
    Azacitidine-extension
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      22
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOCYTOSIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      22
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      37
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      22
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ATRIAL FIBRILLATION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    TACHYCARDIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    ABDOMINAL DISTENSION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ABDOMINAL PAIN
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    ABDOMINAL PAIN UPPER
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    CONSTIPATION
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      22
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    FEBRILE BONE MARROW APLASIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      22
    term
    FEBRILE NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOCYTOSIS
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    LYMPHADENOPATHY
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    NEUTROPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    PANCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    THROMBOCYTOPENIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      153
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      42
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      22
    term
    THROMBOTIC THROMBOCYTOPENIC PURPURA
time Frame
From first dose to 1) last dose + 28 days for azacitidine and low-dose cytarabine; 2) last dose + 70 days for intensive chemotherapy; 3) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively

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