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NCT01861301 · ADVERSE EVENTS

Adverse events

Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma · Source last updated 2016-10-24

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Tivantinib)

Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.

3 / 1817 / 18Not reported / Not reported

Group identifiers: EG000: Treatment (Tivantinib)

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
      1
      num At Risk
      18
    term
    Hypoxia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Lung infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Pleuritic pain
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Small intestinal obstruction

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Alanine aminotransferase increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Alkaline phosphaase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      18
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
    term
    Aspartate aminotransferase increase
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Back pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Blurred vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Bruising
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Chest wall pain
Complete source fields
event Groups
  1. description
    Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    18
    serious Num Affected
    3
    serious Num At Risk
    18
    title
    Treatment (Tivantinib)
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Alanine aminotransferase increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Alkaline phosphaase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      18
    term
    Anemia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      18
    term
    Anorexia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      18
    term
    Aspartate aminotransferase increase
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Back pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Blurred vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Bruising
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      18
    term
    Chest wall pain
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Hypoxia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Lung infection
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Pleuritic pain
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      18
    term
    Small intestinal obstruction

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Preserved source evidence · Not medical advice