Trial Outcomes & Findings for A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (NCT NCT05243550)

Last Updated: 2024-11-04

Results Overview

CRR is defined as the percentage of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

240 participants

Primary outcome timeframe

3 months

Results posted on

2024-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	UGN-102 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Overall Study STARTED	240
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	197

Reasons for withdrawal

Reasons for withdrawal
Measure	UGN-102 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Overall Study Ongoing in the Study	171
Overall Study Withdrawal by Subject	10
Overall Study Lost to Follow-up	7
Overall Study Adverse Event	3
Overall Study Noncompliance	1
Overall Study Physician Decision	1
Overall Study Other Reason	4

Baseline Characteristics

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UGN-102 n=240 Participants 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=93 Participants
Age, Categorical >=65 years	162 Participants n=93 Participants
Age, Continuous	70 years n=93 Participants
Sex: Female, Male Female	93 Participants n=93 Participants
Sex: Female, Male Male	147 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	237 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	234 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment Bulgaria	85 Participants n=93 Participants
Region of Enrollment United States	41 Participants n=93 Participants
Region of Enrollment Latvia	38 Participants n=93 Participants
Region of Enrollment Georgia	20 Participants n=93 Participants
Region of Enrollment Serbia	18 Participants n=93 Participants
Region of Enrollment Estonia	14 Participants n=93 Participants
Region of Enrollment Spain	8 Participants n=93 Participants
Region of Enrollment Lithuania	7 Participants n=93 Participants
Region of Enrollment Poland	7 Participants n=93 Participants
Region of Enrollment Austria	2 Participants n=93 Participants
Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s) Yes	229 Participants n=93 Participants
Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s) No	11 Participants n=93 Participants
Previous LG-NMIBC Episode(s) Within 1 Year Yes	124 Participants n=93 Participants
Previous LG-NMIBC Episode(s) Within 1 Year No	116 Participants n=93 Participants
Prior Transurethral Resection of Bladder Tumor (TURBT) to Treat LG-NMIBC Yes	228 Participants n=93 Participants
Prior Transurethral Resection of Bladder Tumor (TURBT) to Treat LG-NMIBC No	12 Participants n=93 Participants
Longest Tumor Diameter ≤ 3 cm	216 Participants n=93 Participants
Longest Tumor Diameter > 3 cm	19 Participants n=93 Participants
Longest Tumor Diameter Missing	5 Participants n=93 Participants
Tumor Burden ≤ 3 cm	180 Participants n=93 Participants
Tumor Burden > 3 cm	41 Participants n=93 Participants
Tumor Burden Missing	19 Participants n=93 Participants
Tumor Count Single	41 Participants n=93 Participants
Tumor Count Multiple	198 Participants n=93 Participants
Tumor Count Missing	1 Participants n=93 Participants
Smoking History Non-smoker	112 Participants n=93 Participants
Smoking History Smoker	128 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All patients who received any dose of UGN-102.

Outcome measures

Outcome measures
Measure	UGN-102 n=240 Participants 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Complete Response Rate (CRR)	76.7 percentage of participants Interval 70.8 to 81.9

SECONDARY outcome

Timeframe: Up to 60 months

DOR is defined as the time from the first documented CR to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 60 months

DCR rate at scheduled disease assessment time points is defined as the percentage of patients who had a CR at the 3-month Visit and maintained CR up to that particular follow-up visit.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 63 months

DFS is defined as the time from the first instillation to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 21 months

Population: All patients who received any dose of UGN-102.

The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.

Outcome measures

Outcome measures
Measure	UGN-102 n=240 Participants 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest Any TEAEs	137 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest Any serious TEAEs	29 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest Any TEAEs of special interest	100 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All patients who received any dose of UGN-102 and who had a post-baseline laboratory value, except for hemoglobin, which required non-missing laboratory values at baseline and post-baseline.

The number of patients with each type of event is summarized.

Outcome measures

Outcome measures
Measure	UGN-102 n=240 Participants 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Leukocytes ≥ 16.0 × 10^9/L	5 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline	8 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline	0 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Lymphocytes < 0.5 × 10^9/L	1 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Lymphocytes > 20 × 10^9/L	0 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Neutrophils < 1.0 × 10^9/L	1 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Platelets < 75 × 10^9/L	1 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Platelets ≥ 700 × 10^9/L	0 Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values Leukocytes ≤ 2.8 × 10^9/L	2 Participants

SECONDARY outcome

Timeframe: 6 months

Population: All patients who received any dose of UGN-102 and who had a post-baseline laboratory value.

The number of patients with each type of event is summarized.

Outcome measures

Outcome measures
Measure	UGN-102 n=240 Participants 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Number of Participants With Post-baseline PCS Chemistry Values Potassium < 3.0 mmol/L	0 Participants
Number of Participants With Post-baseline PCS Chemistry Values Alanine aminotransferase > 3 × ULN	1 Participants
Number of Participants With Post-baseline PCS Chemistry Values Aspartate aminotransferase > 3 × ULN	1 Participants
Number of Participants With Post-baseline PCS Chemistry Values Bilirubin > 1.5 × ULN	6 Participants
Number of Participants With Post-baseline PCS Chemistry Values Creatinine > 194 μmol/L	8 Participants
Number of Participants With Post-baseline PCS Chemistry Values Gamma glutamyl transferase > 2.5 × ULN	11 Participants
Number of Participants With Post-baseline PCS Chemistry Values Potassium > 5.5 mmol/L	20 Participants
Number of Participants With Post-baseline PCS Chemistry Values Sodium ≤ 130 mmol/L	1 Participants
Number of Participants With Post-baseline PCS Chemistry Values Sodium > 150 mmol/L	0 Participants

Adverse Events

UGN-102

Serious events: 29 serious events

Other events: 129 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	UGN-102 n=240 participants at risk 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Cardiac disorders Atrial fibrillation	0.83% 2/240 • 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. 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.
Cardiac disorders Angina pectoris	0.42% 1/240 • 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. 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.
Cardiac disorders Atrioventricular block second degree	0.42% 1/240 • 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. 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.
Cardiac disorders Cardiac failure	0.42% 1/240 • 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. 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.
Cardiac disorders Cardiac failure acute	0.42% 1/240 • 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. 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.
Cardiac disorders Cardiac failure congestive	0.42% 1/240 • 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. 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.
Cardiac disorders Sinus node dysfunction	0.42% 1/240 • 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. 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.
Infections and infestations COVID-19	0.83% 2/240 • 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. 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.
Infections and infestations Fournier's gangrene	0.42% 1/240 • 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. 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.
Infections and infestations Pneumonia	0.42% 1/240 • 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. 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.
Infections and infestations Urosepsis	0.42% 1/240 • 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. 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.
Nervous system disorders Carotid artery disease	0.42% 1/240 • 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. 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.
Nervous system disorders Carpal tunnel syndrome	0.42% 1/240 • 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. 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.
Nervous system disorders Cerebrovascular accident	0.42% 1/240 • 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. 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.
Nervous system disorders Transient ischaemic attack	0.42% 1/240 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.42% 1/240 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.42% 1/240 • 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. 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.42% 1/240 • 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. 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.
Renal and urinary disorders Urinary retention	0.83% 2/240 • 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. 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.
Renal and urinary disorders Urethral stenosis	0.42% 1/240 • 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. 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.42% 1/240 • 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. 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.42% 1/240 • 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. 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.42% 1/240 • 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. 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.
Gastrointestinal disorders Haemorrhoids	0.42% 1/240 • 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. 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.
Gastrointestinal disorders Incarcerated inguinal hernia	0.42% 1/240 • 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. 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.
Gastrointestinal disorders Nausea	0.42% 1/240 • 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. 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.
Hepatobiliary disorders Gallbladder polyp	0.42% 1/240 • 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. 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.
Hepatobiliary disorders Jaundice cholestatic	0.42% 1/240 • 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. 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.
Injury, poisoning and procedural complications Acetabulum fracture	0.42% 1/240 • 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. 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.
Injury, poisoning and procedural complications Femur fracture	0.42% 1/240 • 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. 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.
Eye disorders Glaucoma	0.42% 1/240 • 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. 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.
General disorders Death	0.42% 1/240 • 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. 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.
Investigations Blood creatinine increased	0.42% 1/240 • 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. 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.
Metabolism and nutrition disorders Hyponatraemia	0.42% 1/240 • 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. 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.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.42% 1/240 • 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. 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.
Vascular disorders Hypertensive crisis	0.42% 1/240 • 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. 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.

Other adverse events

Other adverse events
Measure	UGN-102 n=240 participants at risk 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Renal and urinary disorders Dysuria	22.5% 54/240 • 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. 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.
Renal and urinary disorders Haematuria	8.3% 20/240 • 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. 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.
Renal and urinary disorders Pollakiuria	6.7% 16/240 • 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. 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.
Renal and urinary disorders Urinary retention	4.6% 11/240 • 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. 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.
Infections and infestations Urinary tract infection	7.1% 17/240 • 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. 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.
General disorders Fatigue	5.4% 13/240 • 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. 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.
Renal and urinary disorders Urethral stenosis	4.6% 11/240 • 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. 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.
Renal and urinary disorders Micturition urgency	3.3% 8/240 • 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. 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.
Gastrointestinal disorders Constipation	3.8% 9/240 • 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. 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.
Gastrointestinal disorders Nausea	3.3% 8/240 • 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. 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.

Additional Information

Head of Clinical Development

UroGen Pharma

Phone: +1 855-987-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place