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NCT00887809 · ADVERSE EVENTS

Adverse events

Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes · 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
Gemcitabine, Docetaxel, Bevacizumab

Gemcitabine, Docetaxel, Bevacizumab

12 / 3733 / 37Not reported / Not reported
Gemcitabine, Docetaxel, Placebo

Gemcitabine, Docetaxel, Placebo

6 / 1010 / 10Not reported / Not reported

Group identifiers: EG000: Gemcitabine, Docetaxel, Bevacizumab · EG001: Gemcitabine, Docetaxel, Placebo

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
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      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
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Death not assoc w CTCAE term- Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dyspnea (shortness of breath)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Hemoglobin
  8. 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
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hemorrhage/Bleeding, other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Cellulitis(skin)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Infection unknown Absolute Neutrophil Counts -Pneumonia(lung)

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
      19
      num At Risk
      37
      num Events
      19
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      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
      5
      num At Risk
      37
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    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
      10
      num At Risk
      37
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    ALT, SGPT
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      37
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    AST, SGOT
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Bilirubin (hyperbilirubinemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dyspnea (shortness of breath)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Edema: limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      37
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Glucose, high (hyperglycemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Glucose, low (hypoglycemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      37
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      10
      num Events
      8
    term
    Hemoglobin
Complete source fields
event Groups
  1. description
    Gemcitabine, Docetaxel, Bevacizumab
    id
    EG000
    other Num Affected
    33
    other Num At Risk
    37
    serious Num Affected
    12
    serious Num At Risk
    37
    title
    Gemcitabine, Docetaxel, Bevacizumab
  2. description
    Gemcitabine, Docetaxel, Placebo
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    6
    serious Num At Risk
    10
    title
    Gemcitabine, Docetaxel, Placebo
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
      19
      num At Risk
      37
      num Events
      19
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      10
      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
      5
      num At Risk
      37
      num Events
      5
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    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
      10
      num At Risk
      37
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    ALT, SGPT
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      37
      num Events
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    AST, SGOT
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Bilirubin (hyperbilirubinemia)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dyspnea (shortness of breath)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Edema: limb
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Fatigue (asthenia, lethargy, malaise)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      37
      num Events
      17
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      4
    term
    Glucose, high (hyperglycemia)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Glucose, low (hypoglycemia)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      37
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      10
      num Events
      8
    term
    Hemoglobin
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      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
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Confusion
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Death not assoc w CTCAE term- Death NOS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Dyspnea (shortness of breath)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    Hemoglobin
  8. 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
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hemorrhage/Bleeding, other
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Hypertension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Cellulitis(skin)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    Infection normal Absolute Neutrophil Counts/grade 1/2 neutrophils-Pneumonia(lung)
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTC-3.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    Infection unknown Absolute Neutrophil Counts -Pneumonia(lung)

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