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NCT02187783 · ADVERSE EVENTS

Adverse events

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) · Source last updated 2019-07-18

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
Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) which was an average of 2.7 months up to maximum of 36.2 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Ribociclib 600 mg

LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.

40 / 106104 / 10614 / 106

Group identifiers: EG000: Ribociclib 600 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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Cardio-respiratory arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Dysphagia

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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      106
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      106
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      106
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      106
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      106
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      106
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Chest pain
Complete source fields
event Groups
  1. deaths Num Affected
    14
    deaths Num At Risk
    106
    description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    EG000
    other Num Affected
    104
    other Num At Risk
    106
    serious Num Affected
    40
    serious Num At Risk
    106
    title
    Ribociclib 600 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      106
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      106
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      106
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      106
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      106
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      106
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      106
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      106
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Asthenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      106
    term
    Chest pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Cardio-respiratory arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    term
    Pericardial effusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      106
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      106
    term
    Dysphagia
time Frame
Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) which was an average of 2.7 months up to maximum of 36.2 months.

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