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NCT05243550 · ADVERSE EVENTS

Adverse events

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer · Source last updated 2026-05-11

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
Up to 21 months. Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21.
Other-event reporting threshold
3%

Adverse events (AEs) were reported from the time of informed consent to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment or study procedures were to be reported until the End of Study Visit.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
UGN-102

6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).

29 / 240129 / 2403 / 240

Group identifiers: EG000: UGN-102

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
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      240
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Atrioventricular block second degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure acute
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Sinus node dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      240
    term
    COVID-19
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Fournier's gangrene
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Urosepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Carotid artery disease

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
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      240
    term
    Dysuria
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      240
    term
    Haematuria
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      240
    term
    Pollakiuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      240
    term
    Urinary retention
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      240
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      240
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      240
    term
    Urethral stenosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      240
    term
    Micturition urgency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      240
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      240
    term
    Nausea
Complete source fields
description
Adverse events (AEs) were reported from the time of informed consent to the 6-month Visit. After the 6-month Visit, all serious AEs (regardless of causality) and non-serious AEs assessed as related to study treatment or study procedures were to be reported until the End of Study Visit.
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    240
    description
    6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
    id
    EG000
    other Num Affected
    129
    other Num At Risk
    240
    serious Num Affected
    29
    serious Num At Risk
    240
    title
    UGN-102
frequency Threshold
3
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      240
    term
    Dysuria
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      240
    term
    Haematuria
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      240
    term
    Pollakiuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      240
    term
    Urinary retention
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      240
    term
    Urinary tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      240
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      240
    term
    Urethral stenosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      240
    term
    Micturition urgency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      240
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      240
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      240
    term
    Atrial fibrillation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Atrioventricular block second degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure acute
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Cardiac failure congestive
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Sinus node dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      240
    term
    COVID-19
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Fournier's gangrene
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Urosepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (25.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      240
    term
    Carotid artery disease
time Frame
Up to 21 months. Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21.

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