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NCT00295503 · ADVERSE EVENTS

Adverse events

Cisplatin, Pemetrexed and Bevacizumab for Untreated Malignant Mesothelioma · Source last updated 2020-10-20

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
3 years 6 months
Other-event reporting threshold
1.5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental Arm

cisplatin, pemetrexed, and bevacizumab

16 / 5324 / 53Not reported / Not reported

Group identifiers: EG000: Experimental Arm

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
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    term
    pulmonary embolus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    deep venous thrombosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    RPLS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    cerebrovascular accident
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    small bowel obstruction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    hypoglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    neutropenic fever
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    squamous cell carcinoma of the skin

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
    notes
    Grade 3/4 neutropenia only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Fatigue
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Neuropathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Allergic reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Creatinine
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Mucositis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Vomiting
Complete source fields
event Groups
  1. description
    cisplatin, pemetrexed, and bevacizumab
    id
    EG000
    other Num Affected
    24
    other Num At Risk
    53
    serious Num Affected
    16
    serious Num At Risk
    53
    title
    Experimental Arm
frequency Threshold
1.5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3/4 neutropenia only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
      num Events
      6
    term
    Neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Fatigue
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      53
      num Events
      2
    term
    Neuropathy
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Allergic reaction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Creatinine
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Mucositis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    notes
    Grade 3 and 4 only
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Vomiting
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
      num Events
      5
    term
    pulmonary embolus
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
      num Events
      3
    term
    deep venous thrombosis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    RPLS
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    cerebrovascular accident
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    small bowel obstruction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
      num Events
      4
    term
    Dehydration
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    hypoglycemia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    neutropenic fever
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    Pain
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
      num Events
      1
    term
    squamous cell carcinoma of the skin
time Frame
3 years 6 months

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