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NCT00604461 · ADVERSE EVENTS

Adverse events

Carboplatin, Bevacizumab and Pemetrexed in the First-Line Treatment of Patients With Malignant Pleural Mesothelioma (MPM) · Source last updated 2017-03-23

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
2 Years, 9 MOnths
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation Followed by Maintenance Therapy

A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.

4 / 1313 / 13Not reported / Not reported

Group identifiers: EG000: Dose Escalation Followed by Maintenance Therapy

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
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One patient died within 30 days of starting treatment from an unidentified cause.
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Death
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Thromboembolism

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
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      4
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Cardiac Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Constipation/Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dysgeusia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Elevated Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      3
    term
    Epistaxis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      18
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Herpes Zoster
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      8
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Mucositis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      11
    term
    Nausea/Vomiting
Complete source fields
event Groups
  1. description
    A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m\^2. B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Dose Escalation Followed by Maintenance Therapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
      num Events
      4
    term
    Anorexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Cardiac Arrhythmia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      8
    term
    Constipation/Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Dysgeusia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Elevated Creatinine
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      3
    term
    Epistaxis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      13
      num Events
      18
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Herpes Zoster
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      13
      num Events
      8
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Mucositis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      11
    term
    Nausea/Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    One patient died within 30 days of starting treatment from an unidentified cause.
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Death
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    General disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE V3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Thromboembolism
time Frame
2 Years, 9 MOnths

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