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NCT04640623 · ADVERSE EVENTS

Adverse events

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy · Source last updated 2026-08-28

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
All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Other-event reporting threshold
5%

Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)

Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).

17 / 5351 / 533 / 53
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)

Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.

22 / 8578 / 857 / 85
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)

Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.

3 / 2822 / 280 / 28
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)

Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.

10 / 5244 / 522 / 52

Group identifiers: EG000: Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease) · EG001: Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease) · EG002: Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease) · EG003: Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Aplasia Pure Red Cell
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Atrial Flutter
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Cardiac Failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Mitral Valve Incompetence
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myopericarditis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Phimosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Hypophysitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Retinal Detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Intestinal Perforation

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
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Hyperthyroidism
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Abdominal Pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Stomatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      52
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Fatigue
Complete source fields
description
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    53
    description
    Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
    id
    EG000
    other Num Affected
    51
    other Num At Risk
    53
    serious Num Affected
    17
    serious Num At Risk
    53
    title
    Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
  2. deaths Num Affected
    7
    deaths Num At Risk
    85
    description
    Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    EG001
    other Num Affected
    78
    other Num At Risk
    85
    serious Num Affected
    22
    serious Num At Risk
    85
    title
    Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
  3. deaths Num Affected
    0
    deaths Num At Risk
    28
    description
    Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
    id
    EG002
    other Num Affected
    22
    other Num At Risk
    28
    serious Num Affected
    3
    serious Num At Risk
    28
    title
    Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
  4. deaths Num Affected
    2
    deaths Num At Risk
    52
    description
    Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
    id
    EG003
    other Num Affected
    44
    other Num At Risk
    52
    serious Num Affected
    10
    serious Num At Risk
    52
    title
    Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Hyperthyroidism
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      52
    term
    Abdominal Pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Dry Mouth
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Nausea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Stomatitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      52
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      52
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Aplasia Pure Red Cell
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      52
    term
    Atrial Fibrillation
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Atrial Flutter
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Cardiac Failure
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Mitral Valve Incompetence
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Myopericarditis
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Phimosis
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Hypophysitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Retinal Detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Colitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Diarrhoea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      53
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      85
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      52
    term
    Intestinal Perforation
time Frame
All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice