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NCT01350947 · ADVERSE EVENTS

Adverse events

A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia · Source last updated 2016-06-13

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1 - 5-Azacitidine

All participants enrolled. 5-Azacitidine: Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.

2 / 1111 / 11Not reported / Not reported

Group identifiers: EG000: Arm 1 - 5-Azacitidine

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Fatigue
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    leukocytosis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hematochezia
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    seizure
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    wound treatment

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Abdominal Cramping
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    abdominal pain
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      11
      num Events
      22
    term
    Anemia
  4. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    ankle sprain
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    anorexia
  6. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    term
    anthralgia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      3
    term
    back pain
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Bacteremia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bloating
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bloody discharge from urethra
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bone pain
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Broken Blood Vessel of the Eye
Complete source fields
event Groups
  1. description
    All participants enrolled. 5-Azacitidine: Administered on Days 1-7 of each Cycle. Subcutaneous administration: To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration. The 5-azacitidine suspension is administered subcutaneously. Intravenous Administration: 5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    2
    serious Num At Risk
    11
    title
    Arm 1 - 5-Azacitidine
frequency Threshold
5
other Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    Abdominal Cramping
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    abdominal pain
  3. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      11
      num Events
      22
    term
    Anemia
  4. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    ankle sprain
  5. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    term
    anorexia
  6. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    term
    anthralgia
  7. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      3
    term
    back pain
  8. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Bacteremia
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bloating
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bloody discharge from urethra
  11. organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    bone pain
  12. organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Broken Blood Vessel of the Eye
serious Events
  1. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Fatigue
  2. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    leukocytosis
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Mucositis
  4. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Thrombocytopenia
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hematochezia
  6. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    seizure
  7. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    wound treatment

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Preserved source evidence · Not medical advice