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NCT01418001 · ADVERSE EVENTS

Adverse events

Gemcitabine and Docetaxel in Combination With Pazopanib (Gem/Doce/Pzb) for the Neoadjuvant Treatment of Soft Tissue Sarcoma (STS) · Source last updated 2018-01-11

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
Level 1: Pazopanib 400 mg QD

Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib

3 / 55 / 5Not reported / Not reported

Group identifiers: EG000: Level 1: Pazopanib 400 mg QD

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
    Infections and infestations
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Wound infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Alanine aminotransferase increased

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-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hoarseness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hyperglycemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypertriglyceridemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypoalbuminemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypocalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hyponatremia
Complete source fields
event Groups
  1. description
    Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Level 1: Pazopanib 400 mg QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      5
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hoarseness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hyperglycemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hypertension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypertriglyceridemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypoalbuminemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
    term
    Hypocalcemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Hyponatremia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Wound infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
    term
    Alanine aminotransferase increased

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Preserved source evidence · Not medical advice