Trial Outcomes & Findings for Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG (NCT NCT02449239)
NCT ID: NCT02449239
Last Updated: 2023-07-24
Results Overview
Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
133 participants
Primary outcome timeframe
3 months from start of treatment
Results posted on
2023-07-24
Participant Flow
Participant milestones
| Measure |
Vicinium
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Induction Phase
STARTED
|
133
|
|
Induction Phase
COMPLETED
|
63
|
|
Induction Phase
NOT COMPLETED
|
70
|
|
Maintenance Month 3
STARTED
|
63
|
|
Maintenance Month 3
COMPLETED
|
49
|
|
Maintenance Month 3
NOT COMPLETED
|
14
|
|
Maintenance Month 6
STARTED
|
49
|
|
Maintenance Month 6
COMPLETED
|
36
|
|
Maintenance Month 6
NOT COMPLETED
|
13
|
|
Maintenance Month 9
STARTED
|
36
|
|
Maintenance Month 9
COMPLETED
|
33
|
|
Maintenance Month 9
NOT COMPLETED
|
3
|
|
Maintenance Month 12
STARTED
|
33
|
|
Maintenance Month 12
COMPLETED
|
26
|
|
Maintenance Month 12
NOT COMPLETED
|
7
|
|
Maintenance Month 15
STARTED
|
26
|
|
Maintenance Month 15
COMPLETED
|
25
|
|
Maintenance Month 15
NOT COMPLETED
|
1
|
|
Maintenance Month 18
STARTED
|
25
|
|
Maintenance Month 18
COMPLETED
|
25
|
|
Maintenance Month 18
NOT COMPLETED
|
0
|
|
Maintenance Month 21
STARTED
|
25
|
|
Maintenance Month 21
COMPLETED
|
23
|
|
Maintenance Month 21
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Vicinium
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Induction Phase
Lack of Efficacy
|
64
|
|
Induction Phase
Adverse Event
|
1
|
|
Induction Phase
Lost to Follow-up
|
1
|
|
Induction Phase
Protocol Violation
|
1
|
|
Induction Phase
Physician Decision
|
1
|
|
Induction Phase
Patient was determined by the sponsor to be ineligible for enrollment
|
1
|
|
Induction Phase
Withdrawal by Subject
|
1
|
|
Maintenance Month 3
Lack of Efficacy
|
14
|
|
Maintenance Month 6
Lack of Efficacy
|
10
|
|
Maintenance Month 6
Adverse Event
|
2
|
|
Maintenance Month 6
Physician Decision
|
1
|
|
Maintenance Month 9
Lack of Efficacy
|
2
|
|
Maintenance Month 9
Started ibrutinib for CLL
|
1
|
|
Maintenance Month 12
Lack of Efficacy
|
5
|
|
Maintenance Month 12
Withdrawal by Subject
|
1
|
|
Maintenance Month 12
Subject moved from area
|
1
|
|
Maintenance Month 15
Lack of Efficacy
|
1
|
|
Maintenance Month 21
Lack of Efficacy
|
1
|
|
Maintenance Month 21
Sponsor decision
|
1
|
Baseline Characteristics
Vicinium Treatment for Subjects With Non-muscle Invasive Bladder Cancer Previously Treated With BCG
Baseline characteristics by cohort
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
112 Participants
n=5 Participants
|
|
Age, Continuous
|
73.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
106 Participants
n=5 Participants
|
|
Disease Pathology at Enrollment
CIS with or without concomitant papillary (Ta or T1) disease
|
93 Participants
n=5 Participants
|
|
Disease Pathology at Enrollment
Papillary disease only
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months from start of treatmentPopulation: Patients with CIS with or without concomitant papillary (Ta or T1) disease
Complete response rate at 3 months in patients with CIS with or without resected papillary disease following initiation of Vicinium therapy. This is the percentage of patients who were free of high-grade disease at the post-induction (3 month) assessment timepoint. A patient was considered to have a complete response if the urine cytology was reported as negative or atypical AND the cystoscopy was reported as normal or any suspicious areas were deemed negative for high-grade disease upon biopsy assessment.
Outcome measures
| Measure |
Vicinium
n=93 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Complete Response Rate at 3 Months
|
39 percentage of participants
Interval 29.0 to 49.0
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: Participants with CIS with or without concomitant papillary (Ta or T1) disease who achieved a complete response at 3 months
Duration of complete response in participants with CIS with or without resected papillary disease who achieved a complete response at the post-induction (3 month) assessment. This is the number of days from the date of first occurrence of complete response to the date of documented treatment failure or death, whichever occurs first
Outcome measures
| Measure |
Vicinium
n=36 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Duration of Complete Response
|
273.0 days
Interval 155.0 to
The upper bound of the 95% confidence interval did not reach the 50% threshold
|
SECONDARY outcome
Timeframe: Up to 24 monthsInterval from the date of first dose of study treatment to the first event (persistent high-grade disease or low grade T1 if that was the baseline disease, high-grade disease tumor recurrence, tumor progression to muscle invasive bladder cancer, cystectomy due to treatment failure, or death) prior to treatment discontinuation
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Event-free Survival
|
90.5 days
Interval 81.0 to 179.0
|
SECONDARY outcome
Timeframe: Participants on treatment were assessed at months 6, 9, 12, 15,18, 21, and 24Population: Participants with CIS with or without concomitant papillary (Ta or T1) disease
Complete response rate in subjects with CIS with or without resected papillary disease after 6, 9, 12, 15, 18, 21, and 24 months of Vicinium therapy. This is measured as a proportion of the total number of participants in this group that are free of high-grade disease at the respective 3-month intervals
Outcome measures
| Measure |
Vicinium
n=93 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
6 months
|
28 percentage of participants
Interval 19.0 to 38.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
9 months
|
19 percentage of participants
Interval 12.0 to 29.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
12 months
|
16 percentage of participants
Interval 9.0 to 25.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
15 months
|
14 percentage of participants
Interval 8.0 to 23.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
18 months
|
14 percentage of participants
Interval 8.0 to 23.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
21 months
|
13 percentage of participants
Interval 7.0 to 21.0
|
|
Complete Response Rate at 6, 9, 12, 15, 18, 21, 24 Months
24 months
|
12 percentage of participants
Interval 6.0 to 20.0
|
SECONDARY outcome
Timeframe: Up to 48 monthsTime from the date of first dose of study treatment to physical removal of the bladder
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Time to Cystectomy
|
NA days
The median time to cystectomy was not reached due to an insufficient number of participants with events.
The upper and lower limits of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Participants with high-grade Ta or T1 papillary disease
Time from the first dose of study treatment to the first occurrence of treatment failure or death on or prior to treatment discontinuation for participants with papillary disease only
Outcome measures
| Measure |
Vicinium
n=40 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Time to Disease Recurrence
|
436.0 days
Interval 170.0 to
The upper bound of the 95% confidence interval did not reach the 50% threshold
|
SECONDARY outcome
Timeframe: Up to 24 monthsTime from the date of first dose of study treatment to the date of disease progression (e.g., T2 or more advanced disease) or death on or prior to treatment discontinuation
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Progression-free Survival
|
NA days
The median time to progression-free survival was not reached due to an insufficient number of participants with events.
The upper and lower limits of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 48 months (up to 24 months while on study treatment and up to 24 months in the post-treatment follow-up period from the date of last dose of study drug)All participants were followed for survival during the period of consent (up to 24 months of study treatment and up to 24 months after last dose of study treatment). Any participants who were alive at last follow-up were censored.
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Overall Survival
|
NA days
The median overall survival was not reached due to an insufficient number of participants with events.
The upper and lower limits of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 25 months (up to 24 months of study treatment + 30 days after the last dose of study drug)An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could, therefore, be any unfavorable and unintended sign (that may include an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Any worsening of the participant's pre-existing medical conditions was also considered an AE, unless it was within the normal range of disease fluctuation for that participant.
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
123 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsAn AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could, therefore, be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported.
Outcome measures
| Measure |
Vicinium
n=133 Participants
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Number of Participants That Discontinued Study Treatment Due to an AE
|
4 Participants
|
Adverse Events
Vicinium
Serious events: 21 serious events
Other events: 114 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Vicinium
n=133 participants at risk
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Cardiac disorders
Aortic valve disease
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Cardiac disorders
Pericardial effusion
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Cardiac disorders
Tachycardia
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
3/133 • Number of events 3 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
General disorders
Pyrexia
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Hepatobiliary disorders
Hepatitis cholestasis
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Urinary tract infection
|
1.5%
2/133 • Number of events 2 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Cystitis
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Pyelonephritis
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Injury, poisoning and procedural complications
Fall
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
3/133 • Number of events 4 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Haematuria
|
2.3%
3/133 • Number of events 3 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Renal failure
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Urinary retention
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
1/133 • Number of events 1 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
Other adverse events
| Measure |
Vicinium
n=133 participants at risk
Induction - 30 mg of Vicinium in 50 mL of saline administered twice weekly (BIW) for 6 weeks followed by once weekly for 6 weeks, for a total of 12 weeks.
Maintenance - 30 mg of Vicinium in 50 mL of saline administered once weekly every other week for up to 104 weeks.
Vicinium: Intravesical administration
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
17/133 • Number of events 25 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Nausea
|
12.0%
16/133 • Number of events 20 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Constipation
|
8.3%
11/133 • Number of events 18 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
7/133 • Number of events 12 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
7/133 • Number of events 7 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
General disorders
Fatigue
|
15.8%
21/133 • Number of events 24 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
General disorders
Oedema peripheral
|
11.3%
15/133 • Number of events 16 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
General disorders
Pyrexia
|
6.0%
8/133 • Number of events 10 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Urinary tract infection
|
34.6%
46/133 • Number of events 100 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Nasopharygitis
|
9.8%
13/133 • Number of events 16 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
10/133 • Number of events 10 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Investigations
Lipase increased
|
9.0%
12/133 • Number of events 15 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Investigations
Amylase increased
|
5.3%
7/133 • Number of events 8 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
9/133 • Number of events 15 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
7/133 • Number of events 7 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Nervous system disorders
Headache
|
6.0%
8/133 • Number of events 9 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Dysuria
|
27.8%
37/133 • Number of events 58 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Haematuria
|
26.3%
35/133 • Number of events 53 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Micturition urgency
|
16.5%
22/133 • Number of events 66 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Pollakiuria
|
16.5%
22/133 • Number of events 54 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Urinary incontinence
|
7.5%
10/133 • Number of events 11 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Renal and urinary disorders
Bladder spasm
|
6.0%
8/133 • Number of events 11 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
10/133 • Number of events 13 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
|
Vascular disorders
Hypertension
|
8.3%
11/133 • Number of events 15 • Up to 25 months for adverse events (up to 24 months of study treatment + 30 days after the last dose): Up to 48 months for all-cause mortality (up to 24 months of study treatment + up to 24 months of post-treatment follow-up)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any and all data resulting from the Study will not be presented or published in any form or media by the Institution, Investigator or Research Staff without the prior written consent of Sponsor which consent maybe as directed within the Protocol.
- Publication restrictions are in place
Restriction type: OTHER