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NCT00748657 · ADVERSE EVENTS

Adverse events

Bevacizumab in Treating Patients With Recurrent Sex Cord-Stromal Tumors of the Ovary · Source last updated 2019-07-23

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
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bevacizumab

Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment

13 / 3636 / 36Not reported / Not reported

Group identifiers: EG000: Bevacizumab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    S/N Arrhythmia: Sinus Bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Ulcer,gi - Stomach
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Taste Alteration
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    term
    Obstruction, Gi - Small Bowel Nos
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Inf W/Nml Or Gr 1 Or 2 Anc: Wound
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Hyperuricemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Hyperglycemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Syncope
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Pain: Abdominal Pain Nos

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Allergy/Immunology - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      36
    term
    Rhinitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      36
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Blood/Bone Marrow - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      36
    term
    Hemoglobin
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    term
    Palpitations
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Ventricular Arrhythmia - Tachycardia
Complete source fields
event Groups
  1. description
    Bevacizumab 15 mg/kg IV every 21 days until disease progression or adverse effects prohibit further treatment
    id
    EG000
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    13
    serious Num At Risk
    36
    title
    Bevacizumab
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Allergy/Immunology - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Allergic Reaction/Hypersensitivity
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      36
    term
    Rhinitis
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    term
    Hearing (Without Monitoring Program)
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      36
    term
    Tinnitus
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      36
    term
    Platelets
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Blood/Bone Marrow - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    term
    Leukocytes
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Lymphopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      36
    term
    Hemoglobin
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      36
    term
    Palpitations
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Ventricular Arrhythmia - Tachycardia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Tinnitus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    S/N Arrhythmia: Sinus Bradycardia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Hypertension
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Ulcer,gi - Stomach
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Taste Alteration
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      36
    term
    Obstruction, Gi - Small Bowel Nos
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Inf W/Nml Or Gr 1 Or 2 Anc: Wound
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Hyperuricemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      36
    term
    Hyperglycemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Syncope
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      36
    term
    Pain: Abdominal Pain Nos
time Frame
All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment

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