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NCT00400569 · ADVERSE EVENTS

Adverse events

Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma · Source last updated 2012-08-28

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
4 years, 7 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental: Sunitinib Malate (SU011248) Treatment

Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks

13 / 4839 / 48Not reported / Not reported

Group identifiers: EG000: Experimental: Sunitinib Malate (SU011248) Treatment

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
    Hepatobiliary disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Liver dysfunction/failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Pain - Abdomen
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Death not associated with CTCAE term - Disease progression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Infection with unknown ANC - Peritoneal cavity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Pneumothorax
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Cardiac general
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Hemorrhate/Bleeding
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Left ventricular systolic dysfunction

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 V3
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      48
      num Events
      11
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      48
      num Events
      44
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      48
      num Events
      28
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      48
      num Events
      22
    term
    Mucositis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      48
      num Events
      18
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      48
      num Events
      24
    term
    Dysguesia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      48
      num Events
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      48
      num Events
      27
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
      num Events
      30
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      48
      num Events
      9
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      48
      num Events
      8
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      5
    term
    Hemorrhage/bleeding
Complete source fields
event Groups
  1. description
    Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
    id
    EG000
    other Num Affected
    39
    other Num At Risk
    48
    serious Num Affected
    13
    serious Num At Risk
    48
    title
    Experimental: Sunitinib Malate (SU011248) Treatment
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      48
      num Events
      11
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      48
      num Events
      44
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      48
      num Events
      28
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      48
      num Events
      22
    term
    Mucositis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      48
      num Events
      18
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      48
      num Events
      24
    term
    Dysguesia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      48
      num Events
      22
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      48
      num Events
      27
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      48
      num Events
      30
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      48
      num Events
      9
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      48
      num Events
      8
    term
    Dyspnea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      48
      num Events
      5
    term
    Hemorrhage/bleeding
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Liver dysfunction/failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      4
    term
    Pain - Abdomen
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      48
      num Events
      3
    term
    Death not associated with CTCAE term - Disease progression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Infection with unknown ANC - Peritoneal cavity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Pneumothorax
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Cardiac general
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      48
      num Events
      2
    term
    Hemorrhate/Bleeding
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      48
      num Events
      1
    term
    Left ventricular systolic dysfunction
time Frame
4 years, 7 months

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