Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01831726 · ADVERSE EVENTS

Adverse events

Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib · Source last updated 2017-03-20

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
TKI258

Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.

32 / 8078 / 80Not reported / Not reported

Group identifiers: EG000: TKI258

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 v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Stomatitis

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 v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      80
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      80
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      80
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Dysphagia
Complete source fields
event Groups
  1. description
    Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
    id
    EG000
    other Num Affected
    78
    other Num At Risk
    80
    serious Num Affected
    32
    serious Num At Risk
    80
    title
    TKI258
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Sinus tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      80
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      80
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      80
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      80
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      80
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      80
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      80
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Cardiac arrest
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Dysphagia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      80
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Small intestinal obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      80
    term
    Stomatitis

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice