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NCT03075527 · ADVERSE EVENTS

Adverse events

A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma · Source last updated 2026-07-16

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
Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).
Other-event reporting threshold
0%

A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Tremelimumab + Durvalumab

Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.

4 / 1919 / 1911 / 19

Group identifiers: EG000: Tremelimumab + Durvalumab

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
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Pneumonitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Spinal Cord Compression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Adult respiratory distress syndrome

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Congenital, familial and genetic disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Bloating
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
      num Events
      4
    term
    Constipation
Complete source fields
description
A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    19
    description
    Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression. Tremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack. Durvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
    id
    EG000
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    4
    serious Num At Risk
    19
    title
    Tremelimumab + Durvalumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Sinus bradycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Sinus tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Congenital, familial and genetic disorders - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      19
      num Events
      3
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Ascites
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Bloating
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      19
      num Events
      4
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dysphagia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      19
      num Events
      2
    term
    Pneumonitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Spinal Cord Compression
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Dyspnea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.03)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      19
      num Events
      1
    term
    Adult respiratory distress syndrome
time Frame
Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months).

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Preserved source evidence · Not medical advice