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NCT02793128 · ADVERSE EVENTS

Adverse events

The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study · Source last updated 2020-12-22

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 study period for Adverse Events (AEs) collection was defined from the Informed Consent Form (ICF) signature and up to 30 days following the last administration of investigational product unless the AE was suspected to be related to the study treatment or was a Serious Adverse Event, in such case the AE should be reported regardless to the timelines of the reporting period. Through study completion, an average of 15 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
UGN-101 Mitomycin for Pyelocalyceal Solution

This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT). Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed Low Grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the Primary Disease Evaluation (PDE) Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.

28 / 7167 / 715 / 71

Group identifiers: EG000: UGN-101 Mitomycin for Pyelocalyceal Solution

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
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      71
      num Events
      5
    term
    Ureteric stenosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      71
      num Events
      4
    term
    Hyrdornephrosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Flank Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Urosepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Heamaturia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pelvi-ureteric obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pyelonephritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Ureteric obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Urinary tract obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Arrhythmia

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 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      71
      num Events
      31
    term
    Ureteric stenosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      71
      num Events
      23
    term
    Urinary tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      71
      num Events
      23
    term
    Haematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      71
      num Events
      22
    term
    Flank Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      71
      num Events
      18
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      71
      num Events
      16
    term
    Dysuria
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Renal impairment
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      71
      num Events
      13
    term
    Hydronephrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      71
      num Events
      11
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      71
      num Events
      10
    term
    Anemia
Complete source fields
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    71
    description
    This was a prospective, open-label, single-arm, pivotal phase study, designed to assess the efficacy, tolerability, and safety UGN-101 treatment administered to the Upper Urinary Tract (UUT). Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation. Eligible patients with confirmed Low Grade (LG) noninvasive Upper Tract Urothelial Carcinoma (UTUC) were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the Primary Disease Evaluation (PDE) Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated complete response (CR) could enter a maintenance period and receive up to11 once-monthly instillations, per investigator modified treatment regimen.
    id
    EG000
    other Num Affected
    67
    other Num At Risk
    71
    serious Num Affected
    28
    serious Num At Risk
    71
    title
    UGN-101 Mitomycin for Pyelocalyceal Solution
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      71
      num Events
      31
    term
    Ureteric stenosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      71
      num Events
      23
    term
    Urinary tract infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      71
      num Events
      23
    term
    Haematuria
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      71
      num Events
      22
    term
    Flank Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      71
      num Events
      18
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      71
      num Events
      16
    term
    Dysuria
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Renal impairment
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      71
      num Events
      14
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      71
      num Events
      13
    term
    Hydronephrosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      71
      num Events
      11
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      71
      num Events
      10
    term
    Anemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      71
      num Events
      5
    term
    Ureteric stenosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      71
      num Events
      4
    term
    Hyrdornephrosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Flank Pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      71
      num Events
      3
    term
    Urosepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Heamaturia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      71
      num Events
      2
    term
    Urinary tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pelvi-ureteric obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Pyelonephritis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Ureteric obstruction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Urinary tract obstruction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      71
      num Events
      1
    term
    Arrhythmia
time Frame
The study period for Adverse Events (AEs) collection was defined from the Informed Consent Form (ICF) signature and up to 30 days following the last administration of investigational product unless the AE was suspected to be related to the study treatment or was a Serious Adverse Event, in such case the AE should be reported regardless to the timelines of the reporting period. Through study completion, an average of 15 months.

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