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NCT03228537 · ADVERSE EVENTS

Adverse events

Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma · Source last updated 2026-08-04

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
Duration of treatment and follow up until death or 3 years post registration to Step 1.
Other-event reporting threshold
5%

CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy + Atezolizumab

Participants receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.

11 / 2828 / 286 / 28
Surgery

Within 21-90 days after completion of neoadjuvant therapy, participants undergo EPP or PD. Participants who undergo EPP will then undergo RT.

0 / 1916 / 193 / 19
Maintenance

Within 90 days after completion of either PD or radiation (post-EPP), participants receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.

2 / 1515 / 156 / 15

Group identifiers: EG000: Chemotherapy + Atezolizumab · EG001: Surgery · EG002: Maintenance

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
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Sepsis

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
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Chest pain - cardiac
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Blurred vision
Complete source fields
description
CTCAE version 5.0 was used for reporting SAEs and routine toxicity reporting. There were 28 participants on registration Step 1 (Neoadjuvant) that were assessed for AEs, 19 participants on registration Step 2 (Surgery) that were assessed for AEs, and 15 participants on registration Step 3 (Maintenance) that were assessed for AEs.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    28
    description
    Participants receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    28
    serious Num Affected
    11
    serious Num At Risk
    28
    title
    Chemotherapy + Atezolizumab
  2. deaths Num Affected
    3
    deaths Num At Risk
    19
    description
    Within 21-90 days after completion of neoadjuvant therapy, participants undergo EPP or PD. Participants who undergo EPP will then undergo RT.
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    19
    serious Num Affected
    0
    serious Num At Risk
    19
    title
    Surgery
  3. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    Within 90 days after completion of either PD or radiation (post-EPP), participants receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
    id
    EG002
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    2
    serious Num At Risk
    15
    title
    Maintenance
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Atrial flutter
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Chest pain - cardiac
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Heart failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Supraventricular tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
    term
    Tinnitus
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      15
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Blurred vision
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Tinnitus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Gastritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Infusion related reaction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      15
    term
    Lung infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      19
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      15
    term
    Sepsis
time Frame
Duration of treatment and follow up until death or 3 years post registration to Step 1.

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