Trial Outcomes & Findings for The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study (NCT NCT02793128)
NCT ID: NCT02793128
Last Updated: 2020-12-22
Results Overview
The primary efficacy endpoint was the number of patients attaining complete response (CR) at the end of the treatment period (Primary Disease Evaluation (PDE) visit). The CR was defined dichotomously as "Success" if CR was confirmed at PDE visit (or relevant follow-up), and "Failure" otherwise.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
71 participants
Primary outcome timeframe
An average of 11 weeks
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
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 to 11 once-monthly instillations, per investigator modified treatment regimen.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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 to 11 once-monthly instillations, per investigator modified treatment regimen.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Comorbid conditions and noncompliance
|
1
|
|
Overall Study
Patient elected nephroureterectomy
|
1
|
Baseline Characteristics
The OLYMPUS Study - Optimized DeLivery of Mitomycin for Primary UTUC Study
Baseline characteristics by cohort
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=5 Participants
|
|
Age, Continuous
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of 11 weeksThe primary efficacy endpoint was the number of patients attaining complete response (CR) at the end of the treatment period (Primary Disease Evaluation (PDE) visit). The CR was defined dichotomously as "Success" if CR was confirmed at PDE visit (or relevant follow-up), and "Failure" otherwise.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
The Primary Efficacy Endpoint Was the Number of Patients Attaining Complete Response (CR) at the End of the Treatment Period (PDE Visit).
|
42 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsContinuously: Duration of CR or time-to-recurrence since the Primary Disease Evaluation (PDE) Visit (i.e., time in days from the visit at which CR was determined until recurrence or censoring). This endpoint served as the main long-term durability endpoint. Dichotomously: "Success" if CR was still present at the 12 month post-PDE Visit (at Follow-Up Visit 4), and "Failure" otherwise. This endpoint served as a supportive long-term durability endpoint.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=41 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
The Key Secondary Efficacy Endpoint Was Long-term Durability of Complete Response (CR): Number of Patients Who Maintained CR at 12 Month Post PDE Visit. This Endpoint Was Defined Only for Those Patients Who Achieved CR at the PDE Visit.
|
23 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3, 6, 9 and 12 monthsDurability of CR defined dichotomously as "Success" if CR was achieved at Primary Disease Evaluation (PDE) visit and remained at follow-up Visit 1, Visit 2 and Visit 3 (3, 6, 9 and 12 months post PDE visit), and "Failure" otherwise.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=38 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
n=38 Participants
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
n=35 Participants
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
n=31 Participants
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
Durability of Complete Response (CR) for Each Follow-up Time Point.
|
35 Participants
|
33 Participants
|
28 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: An average of 11 weeksClinical benefit for patients with partial response (PR) at the PDE visit. Clinical benefit endpoint was analyzed using the Intent-to-Treat (ITT) Analysis Set, including patients who achieved partial response at PDE Visit.Partial response at PDE visit will be defined dichotomously, similarly to the primary efficacy endpoint. For subjects with partial response at PDE visit, originally planned and actual treatments will be compared.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
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Clinical Benefit for Patients With Partial Response (PR) at the Primary Disease Evaluation (PDE) Visit. Clinical Benefit Endpoint Was Analyzed Using the Intent-to-Treat (ITT) Analysis Set, Including Patients Who Achieved Partial Response at PDE Visit.
|
8 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation of UGN-101Population: PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
Cmax: maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL). The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=6 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
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Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
|
6.24 ng/mL
Interval 2.43 to 12.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101Population: PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
Tmax: time to maximum plasma concentration Analysis of individual plasma concentration versus time profiles showed that at 6 hours post instillation, the plasma concentrations of all 6 patients were below 2 ng/mL, with the plasma concentration of one patient dropping below the LOQ (i.e., \< 0.100 ng/mL). The mean Cmax was 6.24 ng/mL (range: 2.43 to 12.80 ng/mL), and the Tmax was 1.79 hours (range: 0.50 to 5.17 hours) after instillation. The highest individual observed Cmax value of 12.80 ng/mL was 187-fold and 40 fold lower than the observed Cmax level following an intravenous bolus dose of 30 mg or 10 mg mitomycin (2.4 μg/mL and 0.52 μg/mL, respectively) and is 31 fold lower than the threshold value of 400 ng/mL for myelosuppression observed with mitomycin.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=6 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
|
1.79 Hours
Interval 0.5 to 5.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood samples were collected at 0 minutes (pre-dose) and 30 minutes, 1, 2, 3, 4, 5, and 6 hours following the first instillation with UGN-101Population: PK Analysis Set: Consisted of patients who signed consent for PK and had sufficient PK data for the determination of PK parameters.
Half-life (t½): terminal half-life The mean apparent t½ following instillation of mitomycin into the upper urinary tract (UUT) was 1.27 hours (76 minutes), which was longer than the true t½ of mitomycin following a 30 mg bolus injection (mean t½ value of approximately 17 minutes). The apparent t½ demonstrates that UGN-101 dissolved gradually, resulting in prolonged exposure of mitomycin following local instillation into the UUT.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=6 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
Pharmacokinetic: The PK Profiles of the First UGN-101 Instillation in the Blood Were to be Examined for the First 6 Patients.
|
1.27 Hours
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 15 monthsPopulation: Safety: Consisted of all patients who enrolled in the study and received at least 1 instillation of UGN-101.
Treatment-emergent AEs were most frequently reported from the Renal and urinary disorders system organ class (SOC), 59 (83.1%) patients, as expected, given the underlying indication of low grade (LG) Upper tract urothelial carcinoma (UTUC) in the study population, chemotherapeutic drug in a gel matrix instilled in the upper urinary tract (UUT), and the study procedure of treatment instillation via a ureteral catheter. The toxicity within the upper urinary tract was considered consistent with the disease under study and the mode of administration of UGN-101. Most events in the Renal and urinary disorders SOC were mild to moderate in severity and resolved. No new risks were identified and the overall safety profile was consistent with the known safety profile of endoscopic administration of intravesical mitomycin and of mitomycin. Overall, based on the safety and efficacy results to date, the benefit-risk profile of UGN-101 is favorable for the treatment of LG-UTUC.
Outcome measures
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 Participants
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 UUT. Upon signing of informed consent, the patients underwent a Screening Visit for eligibility evaluation.
Eligible patients with confirmed LG noninvasive UTUC were treated with 6 once-weekly instillations of UGN-101. Tumor response was evaluated at the PDE Visit, 5 weeks after the last treatment period instillation. Patients who demonstrated CR could enter a maintenance period and receive up to 11 once-monthly instillations, per investigator modified treatment regimen.
|
UGN-101 Patients Evaluated at 6 Months Post PDE
Patients reaching CR at PDE evaluated at 6 months post PDE
|
UGN-101 Patients Evaluated at 9 Months Post PDE
Patients reaching CR at PDE evaluated at 9 months post PDE
|
UGN-101 Patients Evaluated at 12 Months Post PDE
Patients reaching CR at PDE evaluated at 12 months post PDE
|
|---|---|---|---|---|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
TEAEs related to study drug or preocedure
|
61 Participants
|
—
|
—
|
—
|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
Serious Adverse Events (SAE)
|
28 Participants
|
—
|
—
|
—
|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
SAEs related to study drug or procedure
|
19 Participants
|
—
|
—
|
—
|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
Treatment-emergent Adverse Events (TEAEs)
|
67 Participants
|
—
|
—
|
—
|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
TEAEs related to study drug
|
52 Participants
|
—
|
—
|
—
|
|
Safety Adverse Event Outcomes: Safety Was Monitored Throughout the Study by Reviewing Adverse Events (AEs).
TEAEs related to study procedure
|
55 Participants
|
—
|
—
|
—
|
Adverse Events
UGN-101 Mitomycin for Pyelocalyceal Solution
Serious events: 28 serious events
Other events: 67 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Ureteric stenosis
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Renal and urinary disorders
Hyrdornephrosis
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Renal and urinary disorders
Flank Pain
|
4.2%
3/71 • Number of events 3 • 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.
|
|
Renal and urinary disorders
Urosepsis
|
4.2%
3/71 • Number of events 3 • 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.
|
|
Renal and urinary disorders
Heamaturia
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Pyelonephritis
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Arrhythmia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac failure acute
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Pulmonary oedema
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Vascular disorders
Aortic dissection
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Vascular disorders
Cerebrovascular accident
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Vascular disorders
Hypotension
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Vascular disorders
Subdural haematoma
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Vascular disorders
Syncope
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
General disorders
Asthenia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
General disorders
Death
|
1.4%
1/71 • Number of events 1 • 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.
|
|
General disorders
Pyrexia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • Number of events 2 • 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.
|
|
Infections and infestations
Gangrene
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Infections and infestations
Pneumonia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Infections and infestations
Septic shock
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
Ankle fracture
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Immune system disorders
Hypersensitivity
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Nervous system disorders
Transient global amnesia
|
1.4%
1/71 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of renal pelvis and ureter metastatic
|
1.4%
1/71 • Number of events 1 • 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 adverse events
| Measure |
UGN-101 Mitomycin for Pyelocalyceal Solution
n=71 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Ureteric stenosis
|
43.7%
31/71 • Number of events 31 • 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.
|
|
Renal and urinary disorders
Urinary tract infection
|
32.4%
23/71 • Number of events 23 • 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.
|
|
Renal and urinary disorders
Haematuria
|
32.4%
23/71 • Number of events 23 • 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.
|
|
Renal and urinary disorders
Flank Pain
|
31.0%
22/71 • Number of events 22 • 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.
|
|
Gastrointestinal disorders
Nausea
|
25.4%
18/71 • Number of events 18 • 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.
|
|
Renal and urinary disorders
Dysuria
|
22.5%
16/71 • Number of events 16 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
19.7%
14/71 • Number of events 14 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
19.7%
14/71 • Number of events 14 • 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.
|
|
Gastrointestinal disorders
Abdominal Pain
|
19.7%
14/71 • Number of events 14 • 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.
|
|
Renal and urinary disorders
Hydronephrosis
|
18.3%
13/71 • Number of events 13 • 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.
|
|
General disorders
Fatigue
|
15.5%
11/71 • Number of events 11 • 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.
|
|
Blood and lymphatic system disorders
Anemia
|
14.1%
10/71 • Number of events 10 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.1%
10/71 • Number of events 10 • 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.
|
|
Renal and urinary disorders
Pollakiuria
|
14.1%
10/71 • Number of events 10 • 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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
9/71 • Number of events 9 • 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.
|
|
General disorders
Pyrexia
|
12.7%
9/71 • Number of events 9 • 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.
|
|
General disorders
Chills
|
11.3%
8/71 • Number of events 8 • 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.
|
|
General disorders
Asthenia
|
11.3%
8/71 • Number of events 8 • 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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.9%
7/71 • Number of events 7 • 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.
|
|
Vascular disorders
Hypertension
|
9.9%
7/71 • Number of events 7 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.5%
6/71 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
6/71 • Number of events 6 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
8.5%
6/71 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
8.5%
6/71 • Number of events 6 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.5%
6/71 • Number of events 6 • 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.
|
|
Gastrointestinal disorders
Constipation
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Nervous system disorders
Headache
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Renal and urinary disorders
urinary tract inflammation
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
7.0%
5/71 • Number of events 5 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Psychiatric disorders
Depression
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Renal and urinary disorders
urine abnormality
|
5.6%
4/71 • Number of events 4 • 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.
|
|
Metabolism and nutrition disorders
Weight loss poor
|
5.6%
4/71 • Number of events 4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place