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NCT04158141 · ADVERSE EVENTS

Adverse events

Testing the Addition of Targeted Radiation Therapy to Surgery and the Usual Chemotherapy Treatment (Pemetrexed and Cisplatin [or Carboplatin]) for Stage I-IIIA Malignant Pleural Mesothelioma · Source last updated 2026-07-13

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
Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.
Other-event reporting threshold
5%

All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pre-randomization

All patients in Step 1. STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.

0 / 1313 / 130 / 16
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)

\[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.

0 / 43 / 40 / 5
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)

\[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.

0 / 63 / 62 / 6

Group identifiers: EG000: Pre-randomization · EG001: Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment) · EG002: Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    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
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Anemia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Blood and lymphatic system disorders - Other
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Febrile neutropenia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Leukocytosis
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Palpitations
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Tinnitus
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Eye disorders - Other
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Watering eyes
    9. 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
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Abdominal distension
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Abdominal pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Chylous ascites
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Constipation
    Complete source fields
    description
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants who started any protocol treatment and were assessed for adverse events.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      16
      description
      All patients in Step 1. STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.
      id
      EG000
      other Num Affected
      13
      other Num At Risk
      13
      serious Num Affected
      0
      serious Num At Risk
      13
      title
      Pre-randomization
    2. deaths Num Affected
      0
      deaths Num At Risk
      5
      description
      \[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.
      id
      EG001
      other Num Affected
      3
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
    3. deaths Num Affected
      2
      deaths Num At Risk
      6
      description
      \[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
      id
      EG002
      other Num Affected
      3
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Anemia
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Blood and lymphatic system disorders - Other
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Febrile neutropenia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Leukocytosis
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Palpitations
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Tinnitus
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Eye disorders - Other
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Watering eyes
    9. 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
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Abdominal distension
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Abdominal pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        6
      term
      Chylous ascites
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE 5.0
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        13
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        4
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        6
      term
      Constipation
    time Frame
    Pre-randomization: From registration (Step 1) to randomization (Step 2). The timing of randomization could vary from approximately 8 weeks to 32 weeks, depending on several factors. Arm 1 and Arm 2: From randomization to last follow-up. Maximum follow-up was 25 months.

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