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NCT03126630 · ADVERSE EVENTS

Adverse events

Pembrolizumab With or Without Anetumab Ravtansine in Treating Patients With Mesothelin-Positive Pleural Mesothelioma · Source last updated 2026-04-01

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
Up to 2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 2 Group I (Pembrolizumab)

Pharmacological Study: Correlative studies

1 / 1717 / 171 / 17
Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)

Pharmacological Study: Correlative studies

2 / 1818 / 182 / 18
Phase 1 Cohort DLT 1

Anetumab Ravtansine Dose 6.5 mg/kg

1 / 1313 / 131 / 13

Group identifiers: EG000: Phase 2 Group I (Pembrolizumab) · EG001: Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab) · EG002: Phase 1 Cohort DLT 1

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
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Gen disord and admin site conds-Oth spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Neoplasms benign, mal, uncpec - Oth spec

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
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      17
      num Events
      42
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
      num Events
      32
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      13
      num Events
      54
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
      num Events
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      12
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ear and labyrinth disorders - Oth spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Endocrine disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      6
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hypoparathyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
      num Events
      32
    term
    Hypothyroidism
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    17
    description
    Pharmacological Study: Correlative studies
    id
    EG000
    other Num Affected
    17
    other Num At Risk
    17
    serious Num Affected
    1
    serious Num At Risk
    17
    title
    Phase 2 Group I (Pembrolizumab)
  2. deaths Num Affected
    2
    deaths Num At Risk
    18
    description
    Pharmacological Study: Correlative studies
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    2
    serious Num At Risk
    18
    title
    Phase 2 Group II (Anetumab Ravtansine, Pembrolizumab)
  3. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Anetumab Ravtansine Dose 6.5 mg/kg
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    1
    serious Num At Risk
    13
    title
    Phase 1 Cohort DLT 1
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      17
      num Events
      42
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      18
      num Events
      32
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      13
      num Events
      54
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      9
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      18
      num Events
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      12
    term
    Blood and lymph sys disorders - Oth Spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Cardiac disorders - Other, specify
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Heart failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      18
      num Events
      17
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ear and labyrinth disorders - Oth spec
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Ear pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Endocrine disorders - Other, specify
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      6
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Hypoparathyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      17
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      13
      num Events
      32
    term
    Hypothyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Death NOS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      17
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Gen disord and admin site conds-Oth spec
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE 4
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      17
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Neoplasms benign, mal, uncpec - Oth spec
time Frame
Up to 2 years

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