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NCT03175172 · ADVERSE EVENTS

Adverse events

Evaluation of CRS-207 With Pembrolizumab in Previously Treated Malignant Pleural Mesothelioma (MPM) · Source last updated 2019-04-04

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
Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 28 days following the last dose of study drug or initiation of a subsequent cancer-related therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for 12 months after end-of-treatment (EOT) or until study termination on 31 January 2018, whichever is earlier, an average of 14 weeks.
Other-event reporting threshold
0%

AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental

CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by IV infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 CFU) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).

4 / 1010 / 103 / 10

Group identifiers: EG000: Experimental

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    DYSPNOEA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    HYPOXIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    PNEUMONITIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    HYPOTENSION

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
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      10
    term
    CHILLS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    PYREXIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    OEDEMA PERIPHERAL
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    FATIGUE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    OEDEMA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    DYSPNOEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    HYPOXIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    COUGH
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    DYSPNOEA EXERTIONAL
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    PNEUMONITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    WHEEZING
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    NAUSEA
Complete source fields
description
AEs reported for the SAF. Methods of determining whether certain AEs have occurred include regular investigator assessment and regular laboratory testing.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    10
    description
    CRS-207 and pembrolizumab were administered in 3-week cycles. For Cycle 1, pembrolizumab (200 mg) was administered by IV infusion over 30 minutes on Day 1 and CRS-207 (starting dose 1 × 10e9 CFU) was administered by IV infusion over 1 hour on Day 2. If tolerated, pembrolizumab and CRS-207 were administered on the same day (Day 1) for subsequent cycles. After 4 cycles, pembrolizumab continued to be administered on Day 1 at each treatment cycle (every 3 weeks); and CRS-207 was administered once every 6 weeks (every other cycle).
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Experimental
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      10
    term
    CHILLS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      10
    term
    PYREXIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    OEDEMA PERIPHERAL
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    FATIGUE
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    OEDEMA
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    DYSPNOEA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    term
    HYPOXIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    term
    COUGH
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    DYSPNOEA EXERTIONAL
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    PNEUMONITIS
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    WHEEZING
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    term
    NAUSEA
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    DYSPNOEA
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    HYPOXIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    PNEUMONITIS
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (19.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    term
    HYPOTENSION
time Frame
Subjects were followed for serious and non-serious adverse events (AEs) from the beginning of any study drug until 28 days following the last dose of study drug or initiation of a subsequent cancer-related therapy, whichever is earlier, an average of 3 months. Subjects were followed for survival for 12 months after end-of-treatment (EOT) or until study termination on 31 January 2018, whichever is earlier, an average of 14 weeks.

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Preserved source evidence · Not medical advice