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NCT00859469 · ADVERSE EVENTS

Adverse events

Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma · Source last updated 2019-10-30

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
50 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Oxaliplatin and Gemcitabine

The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.

11 / 2827 / Not reportedNot reported / Not reported

Group identifiers: EG000: Oxaliplatin and Gemcitabine

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
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Dyspnea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated alkaline phosphatase
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated AST
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated ALT
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Elevated Bilirubin

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
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      28
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      26
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
    term
    Elevated alkaline phosphatase
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    Elevated AST
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    term
    Elevated ALT
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      29
    term
    Nausea/Vomiting
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      29
    term
    Peripheral neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Fever
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Vertigo
Complete source fields
event Groups
  1. description
    The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
    id
    EG000
    other Num Affected
    27
    serious Num Affected
    11
    serious Num At Risk
    28
    title
    Oxaliplatin and Gemcitabine
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
    term
    Leukopenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      28
    term
    Thrombocytopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      26
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
    term
    Elevated alkaline phosphatase
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      26
    term
    Elevated AST
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      26
    term
    Elevated ALT
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      29
    term
    Nausea/Vomiting
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      29
    term
    Peripheral neuropathy
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Fever
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Alopecia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      29
    term
    Vertigo
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Dyspnea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated alkaline phosphatase
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated AST
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    term
    Elevated ALT
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    SNOMED CT
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    term
    Elevated Bilirubin
time Frame
50 months

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Preserved source evidence · Not medical advice