Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05041062 · ADVERSE EVENTS

Adverse events

A Study of Immunotherapy Drugs Nivolumab and Ipilimumab in Patients w/Resectable Malignant Peritoneal Mesothelioma · Source last updated 2024-01-03

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
12 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Participants in Study Who Have Mesothelioma

Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.

2 / 22 / 20 / 2

Group identifiers: EG000: All Participants in Study Who Have Mesothelioma

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
    Renal and urinary disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
    term
    Acute kidney injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Encephalopathy

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
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Respiratory, thoracic and mediastinal disorders-Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Dry mouth
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Rash
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Diarrhea
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Individuals in this group will receive a combination of two immunotherapy drugs (nivolumab and ipilimumab) before and after surgery to remove their cancer. Nivolumab: Nivolumab is an immunotherapy drug (a type of drug that helps the immune system fight cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion. Ipilimumab: Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps the immune system attack cancer cells.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    All Participants in Study Who Have Mesothelioma
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Pain
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Respiratory, thoracic and mediastinal disorders-Other
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Dry mouth
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Rash
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Vomiting
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Anorexia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Diarrhea
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2
    term
    Acute kidney injury
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE 5.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    term
    Encephalopathy
time Frame
12 weeks

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice