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NCT02201329 · ADVERSE EVENTS

Adverse events

Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia · Source last updated 2018-07-30

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 drug administration until 30 days after last trial drug administration in the last treatment cycle or the decision of study treatment discontinuation, whichever is later, and was up to 389 days.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Volasertib 200 mg

The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.

2 / 55 / 5Not reported / Not reported

Group identifiers: EG000: Volasertib 200 mg

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 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypersensitivity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Pyelonephritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Acute kidney injury

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Eyelids pruritus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Enterocolitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Tongue coated
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Fatigue
Complete source fields
event Groups
  1. description
    The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Volasertib 200 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Arrhythmia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Eyelids pruritus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Enterocolitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Tongue coated
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Disseminated intravascular coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypersensitivity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Pyelonephritis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Dehydration
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 18.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Acute kidney injury
time Frame
From first drug administration until 30 days after last trial drug administration in the last treatment cycle or the decision of study treatment discontinuation, whichever is later, and was up to 389 days.

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