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NCT03710876 · ADVERSE EVENTS

Adverse events

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-04-21

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
The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months. Safety follow-up for patients in the active treatment group continued for each individual for a period of five years from initial dosing. During this period no further safety events were observed and no updates to the CSR were required. The LPLV was on 16 January 2026.
Other-event reporting threshold
5%

Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.

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

rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

10 / 2727 / 2724 / 27
Control Group

Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination

12 / 2222 / 2219 / 26

Group identifiers: EG000: Treatment Group · EG001: Control Group

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
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      4
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hypoxia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Clostridium difficile infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Lower respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Pleural infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Pneumonia viral

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      27
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
      num Events
      20
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
      num Events
      12
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
      num Events
      9
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Malaise
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cather site extravasation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
      num Events
      10
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Pleural effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Dyspnoea exertional
Complete source fields
description
Standard (S)AE definitions. The Intent-to-Treat (ITT) Analysis Set comprised all randomized patients; this represents the population for the calculation of All-Cause Mortality. The Safety Analysis Set comprised all patients who received at least 1 dose of study drug; this represents the population for presentation of the Adverse Events data.
event Groups
  1. deaths Num Affected
    24
    deaths Num At Risk
    27
    description
    rAd-IFN (Study Day 1) + celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/early termination \[ET\] rAd-IFN: Adenovirus-Delivered Interferon Alpha-2b Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    10
    serious Num At Risk
    27
    title
    Treatment Group
  2. deaths Num Affected
    19
    deaths Num At Risk
    26
    description
    Celecoxib (Study Days 1 to 14) + gemcitabine (Study Days 14 and 21 \[i.e., Days 1 and 8 of the first gemcitabine treatment cycle\], gemcitabine will be administered on a 21-day cycle, unless the cycle is modified due to toxicity/delay, and repeated every 3 weeks until disease progression/ET. Celecoxib Oral Product: 400 mg twice daily Gemcitabine: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21-day cycle and continued every 3 weeks until disease progression/ early termination
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    12
    serious Num At Risk
    22
    title
    Control Group
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      27
      num Events
      27
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
      num Events
      20
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
      num Events
      7
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      22
      num Events
      12
    term
    Pyrexia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      27
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      22
      num Events
      5
    term
    Asthenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      27
      num Events
      8
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      22
      num Events
      9
    term
    Oedema peripheral
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Non-cardiac chest pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Chest pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Malaise
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cather site extravasation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      27
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      22
      num Events
      10
    term
    Dyspnoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      27
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      22
      num Events
      3
    term
    Pleural effusion
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      27
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Dyspnoea exertional
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      4
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      27
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Dyspnoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hypoxia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac failure
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      22
      num Events
      2
    term
    Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Clostridium difficile infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Lower respiratory tract infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      27
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Pleural infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      27
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      22
      num Events
      1
    term
    Pneumonia viral
time Frame
The Safety Analysis Set comprises all patients who received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine), from study start on 27 August 2019 to Data Cut-off on 07 May 2024, a period of 4 years and 8 months. Safety follow-up for patients in the active treatment group continued for each individual for a period of five years from initial dosing. During this period no further safety events were observed and no updates to the CSR were required. The LPLV was on 16 January 2026.

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