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NCT03502746 · ADVERSE EVENTS

Adverse events

Phase II Nivolumab and Ramucirumab for Patients With Previously-Treated Mesothelioma · Source last updated 2024-05-14

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
All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Nivolumab + Ramucirumab

Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.

9 / 3434 / 3422 / 34

Group identifiers: EG000: Nivolumab + Ramucirumab

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
    Cardiac disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ATRIAL FIBRILLATION
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DEHYDRATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DIARRHEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DYSPNEA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ESOPHAGEAL OBSTRUCTION
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    HEART FAILURE
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    LOWER GASTROINTESTINAL HEMORRHAGE
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    MUSCLE WEAKNESS LOWER LIMB
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    PANCREATITIS

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
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ABDOMINAL PAIN
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ALLERGIC REACTION
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ALLERGIC RHINITIS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      3
    term
    ANEMIA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      12
    term
    ANOREXIA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    ANXIETY
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    term
    ARTHRALGIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    ARTHRITIS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ASPARTATE AMINOTRANSFERASE INCREASED
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      5
    term
    BACK PAIN
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    BONE PAIN
Complete source fields
event Groups
  1. deaths Num Affected
    22
    deaths Num At Risk
    34
    description
    Nivolumab 240mg IV + Ramucirumab 8mg/kg IV Nivolumab: Nivolumab 240mg, IV over 30 minutes. Ramucirumab: 8mg/kg, IV over 60 minutes.
    id
    EG000
    other Num Affected
    34
    other Num At Risk
    34
    serious Num Affected
    9
    serious Num At Risk
    34
    title
    Nivolumab + Ramucirumab
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ABDOMINAL DISTENSION
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ABDOMINAL PAIN
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ALLERGIC REACTION
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ALLERGIC RHINITIS
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      3
    term
    ANEMIA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      34
      num Events
      12
    term
    ANOREXIA
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      3
    term
    ANXIETY
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      34
      num Events
      5
    term
    ARTHRALGIA
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      34
      num Events
      3
    term
    ARTHRITIS
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ASPARTATE AMINOTRANSFERASE INCREASED
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      34
      num Events
      5
    term
    BACK PAIN
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    BONE PAIN
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      34
      num Events
      2
    term
    ATRIAL FIBRILLATION
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DEHYDRATION
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DIARRHEA
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    DYSPNEA
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    ESOPHAGEAL OBSTRUCTION
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    HEART FAILURE
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    LOWER GASTROINTESTINAL HEMORRHAGE
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    MUSCLE WEAKNESS LOWER LIMB
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAEv4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      34
      num Events
      1
    term
    PANCREATITIS
time Frame
All-Cause Mortality was monitored up to a maximum of 32 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.

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Preserved source evidence · Not medical advice