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NCT01757535 · ADVERSE EVENTS

Adverse events

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission · Source last updated 2025-07-08

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 day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oral Azacitidine Plus Best Supportive Care

Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.

110 / 236235 / 236172 / 238
Placebo Plus Best Supportive Care

Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.

109 / 233224 / 233176 / 234

Group identifiers: EG000: Oral Azacitidine Plus Best Supportive Care · EG001: Placebo Plus Best Supportive Care

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      233
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      233
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      233
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Thrombocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Aortic valve disease

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      233
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      233
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      233
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      233
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      233
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      233
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      233
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      233
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      233
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      233
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      233
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      233
    term
    Haemorrhoids
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
event Groups
  1. deaths Num Affected
    172
    deaths Num At Risk
    238
    description
    Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
    id
    EG000
    other Num Affected
    235
    other Num At Risk
    236
    serious Num Affected
    110
    serious Num At Risk
    236
    title
    Oral Azacitidine Plus Best Supportive Care
  2. deaths Num Affected
    176
    deaths Num At Risk
    234
    description
    Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
    id
    EG001
    other Num Affected
    224
    other Num At Risk
    233
    serious Num Affected
    109
    serious Num At Risk
    233
    title
    Placebo Plus Best Supportive Care
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      233
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      233
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      233
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      233
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      233
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      233
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      233
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      233
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      233
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      233
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      233
    term
    Flatulence
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      233
    term
    Haemorrhoids
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      233
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      233
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Lymphadenitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      233
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Thrombocytosis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      233
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      233
    term
    Aortic valve disease
time Frame
From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months

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