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NCT01675765 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma · Source last updated 2020-09-30

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
From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 5 years from the date of randomization.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Immunotherapy Plus Chemotherapy

Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm

15 / 3838 / 383 / 38
Immunotherapy With Cyclophosphamide Plus Chemotherapy

Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

11 / 2222 / 220 / 22

Group identifiers: EG000: Immunotherapy Plus Chemotherapy · EG001: Immunotherapy With Cyclophosphamide Plus Chemotherapy

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
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Diverticular perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Gastric ulcer haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Large intestine perforation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Pancreatitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Small intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Haemothorax

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
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
    term
    Chills
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      22
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Chest pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      22
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Diarrhoea
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    38
    description
    Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
    id
    EG000
    other Num Affected
    38
    other Num At Risk
    38
    serious Num Affected
    15
    serious Num At Risk
    38
    title
    Immunotherapy Plus Chemotherapy
  2. deaths Num Affected
    0
    deaths Num At Risk
    22
    description
    Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    11
    serious Num At Risk
    22
    title
    Immunotherapy With Cyclophosphamide Plus Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      22
    term
    Chills
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      22
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    Fatigue
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Malaise
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Chest pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      22
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
    term
    Vomiting
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      22
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Abdominal pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Diverticular perforation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Gastric ulcer haemorrhage
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
    term
    Large intestine perforation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Pancreatitis acute
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Small intestinal obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Dyspnoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      38
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
    term
    Haemothorax
time Frame
From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 5 years from the date of randomization.

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