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NCT00397488 · ADVERSE EVENTS

Adverse events

Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium · Source last updated 2016-01-25

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

Sunitinib in patients with metastatic urothelial carcinoma.

34 / 7867 / 78Not reported / Not reported

Group identifiers: EG000: Sunitinib

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
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Creatinine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Death not associated with CTCAE term- Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Death not associated with CTCAE term-Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Dehydration
  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
      78
      num Events
      1
    term
    Distension/bloating, abdominal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Extremity-lower (gait/walking)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Fever (in the absence of neutropenia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Fistula, GI- Small bowel
  12. 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
      78
      num Events
      1
    term
    Hemoglobin

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
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
      num Events
      6
    term
    Albumin, low (hypoalbuminemia)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Alkaline phosphatase
  3. 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
      78
      num Events
      5
    term
    ALT, SGPT
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
      num Events
      6
    term
    AST, SGOT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      78
      num Events
      13
    term
    Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      78
      num Events
      28
    term
    Fatigue (asthenia, lethargy, malaise)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      78
      num Events
      18
    term
    Glucose, high (hyperglycemia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Heartburn/dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      78
      num Events
      28
    term
    Hemoglobin
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Hemorrhage, Urinary NOS
Complete source fields
event Groups
  1. description
    Sunitinib in patients with metastatic urothelial carcinoma.
    id
    EG000
    other Num Affected
    67
    other Num At Risk
    78
    serious Num Affected
    34
    serious Num At Risk
    78
    title
    Sunitinib
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
      num Events
      6
    term
    Albumin, low (hypoalbuminemia)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      78
      num Events
      8
    term
    Alkaline phosphatase
  3. 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
      78
      num Events
      5
    term
    ALT, SGPT
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      78
      num Events
      6
    term
    AST, SGOT
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      78
      num Events
      13
    term
    Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      78
      num Events
      28
    term
    Fatigue (asthenia, lethargy, malaise)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      78
      num Events
      18
    term
    Glucose, high (hyperglycemia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Heartburn/dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      78
      num Events
      28
    term
    Hemoglobin
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      78
      num Events
      5
    term
    Hemorrhage, Urinary NOS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Creatinine
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      78
      num Events
      4
    term
    Death not associated with CTCAE term- Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Death not associated with CTCAE term-Disease progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Dehydration
  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
      78
      num Events
      1
    term
    Distension/bloating, abdominal
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Extremity-lower (gait/walking)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      78
      num Events
      2
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Fever (in the absence of neutropenia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      78
      num Events
      1
    term
    Fistula, GI- Small bowel
  12. 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
      78
      num Events
      1
    term
    Hemoglobin

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