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NCT03319537 · ADVERSE EVENTS

Adverse events

Pevonedistat Alone and in Combination With Chemotherapy in Patients With Mesothelioma · Source last updated 2024-05-23

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
1 year
Other-event reporting threshold
0%

No participants accrued to Pevonedistat in Combination With Pemetrexed and Cisplatin cohort

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pevonedistat

pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient.

3 / 97 / 98 / 9
Pevonedistat in Combination With Pemetrexed and Cisplatin

pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient. Pemetrexed and cisplatin: Pemetrexed, 500 mg/m2 and cisplatin, 75 mg/m2, will be given at fixed doses on day 1 of each cycle.

0 / 00 / 00 / 0

Group identifiers: EG000: Pevonedistat · EG001: Pevonedistat in Combination With Pemetrexed and Cisplatin

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Upper Gastrointestinal Hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Back Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Neoplasms ben/mal/unk (inc cyst/polyp
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Death 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
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Abdominal Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Chest wall pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Decreased appetite
Complete source fields
description
No participants accrued to Pevonedistat in Combination With Pemetrexed and Cisplatin cohort
event Groups
  1. deaths Num Affected
    8
    deaths Num At Risk
    9
    description
    pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    9
    serious Num Affected
    3
    serious Num At Risk
    9
    title
    Pevonedistat
  2. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    pevonedistat: Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient. Pemetrexed and cisplatin: Pemetrexed, 500 mg/m2 and cisplatin, 75 mg/m2, will be given at fixed doses on day 1 of each cycle.
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Pevonedistat in Combination With Pemetrexed and Cisplatin
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Abdominal Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Allergic rhinitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Anorexia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Back pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Chest wall pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Cough
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Decreased appetite
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Upper Gastrointestinal Hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Back Pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Neoplasms ben/mal/unk (inc cyst/polyp
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      9
    2. group Id
      EG001
      num At Risk
      0
    term
    Death NOS
time Frame
1 year

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Preserved source evidence · Not medical advice