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NCT00474994 · ADVERSE EVENTS

Adverse events

Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas · Source last updated 2016-01-20

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
Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

9 / 5337 / 53Not reported / Not reported

Group identifiers: EG000: Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas

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
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Death not associated with CTCAE term- Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Death not associated with CTCAE term-Disease progression NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Dizziness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    term
    Hemoglobin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pain - Abdomen NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pneumothorax
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    term
    Seizure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      3
    term
    Ulcer, Duodenum

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
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    AST, SGOT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Bilirubin (hyperbilirubinemia)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    term
    Fatigue (asthenia, lethargy, malaise)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    Gastrointestinal, other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    term
    Hemoglobin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
      num Events
      9
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      53
      num Events
      14
    term
    Leukocytes (total WBC)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Mucositis (Clincal exam)- Oral cavity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
      num Events
      15
    term
    Neutrophils/granulocytes (ANC/AGC)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Platelets
Complete source fields
event Groups
  1. description
    Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
    id
    EG000
    other Num Affected
    37
    other Num At Risk
    53
    serious Num Affected
    9
    serious Num At Risk
    53
    title
    Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    AST, SGOT
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Bilirubin (hyperbilirubinemia)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    term
    Fatigue (asthenia, lethargy, malaise)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    Gastrointestinal, other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    term
    Hemoglobin
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      53
      num Events
      9
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      53
      num Events
      14
    term
    Leukocytes (total WBC)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    Lymphopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Mucositis (Clincal exam)- Oral cavity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      53
      num Events
      15
    term
    Neutrophils/granulocytes (ANC/AGC)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      53
      num Events
      7
    term
    Platelets
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Death not associated with CTCAE term- Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Death not associated with CTCAE term-Disease progression NOS
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Dizziness
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    term
    Hemoglobin
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pain - Abdomen NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Platelets
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pneumothorax
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      2
    term
    Seizure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      3
    term
    Ulcer, Duodenum

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Preserved source evidence · Not medical advice