Trial Outcomes & Findings for Instillation of Gemcitabine in Patients With Superficial Bladder Cancer (NCT NCT00191477)
NCT ID: NCT00191477
Last Updated: 2009-10-28
Results Overview
Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)
Results posted on
2009-10-28
Participant Flow
355 participants were enrolled and randomized (included here in disposition); however, due to study design, only 328 (N=166 Gemcitabine and N=162 Placebo) actually received study drug (Full Analysis Set).
Participant milestones
| Measure |
Gemcitabine
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Overall Study
STARTED
|
179
|
176
|
|
Overall Study
Received Study Drug
|
166
|
162
|
|
Overall Study
COMPLETED
|
41
|
47
|
|
Overall Study
NOT COMPLETED
|
138
|
129
|
Reasons for withdrawal
| Measure |
Gemcitabine
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Overall Study
Tumor Recurrence
|
49
|
48
|
|
Overall Study
Death, Study Disease
|
1
|
1
|
|
Overall Study
Death, Other Cause
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
23
|
21
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Treatment Change
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Not Eligible
|
41
|
38
|
|
Overall Study
Pathological Specimen Lost
|
1
|
0
|
|
Overall Study
Discontinued Prior to Instillation
|
13
|
14
|
Baseline Characteristics
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=166 Participants
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
n=162 Participants
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
66.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
65.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
263.0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
131 participants
n=5 Participants
|
126 participants
n=7 Participants
|
257.0 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
71.0 participants
n=5 Participants
|
|
Karnofsky Performance Status
70 - Unable to carry on normal activity
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2.0 participants
n=5 Participants
|
|
Karnofsky Performance Status
80 - Activity with effort; some signs of disease
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20.0 participants
n=5 Participants
|
|
Karnofsky Performance Status
90 - Normal activity; minor signs of disease
|
33 participants
n=5 Participants
|
49 participants
n=7 Participants
|
82.0 participants
n=5 Participants
|
|
Karnofsky Performance Status
100 - Normal no complaints; no evidence of disease
|
118 participants
n=5 Participants
|
104 participants
n=7 Participants
|
222.0 participants
n=5 Participants
|
|
Karnofsky Performance Status
Unspecified
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2.0 participants
n=5 Participants
|
|
Newly Diagnosed versus Recurrent Disease
Recurrent Disease
|
43 participants
n=5 Participants
|
40 participants
n=7 Participants
|
83.0 participants
n=5 Participants
|
|
Newly Diagnosed versus Recurrent Disease
Newly Diagnosed
|
123 participants
n=5 Participants
|
122 participants
n=7 Participants
|
245.0 participants
n=5 Participants
|
|
Race/Ethnicity
White
|
166 participants
n=5 Participants
|
162 participants
n=7 Participants
|
328 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
No Lesions (No Specific Sites Documented)
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9.0 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
1 Lesion
|
87 participants
n=5 Participants
|
96 participants
n=7 Participants
|
183.0 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
2 Lesions
|
42 participants
n=5 Participants
|
27 participants
n=7 Participants
|
69.0 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
3 Lesions
|
18 participants
n=5 Participants
|
14 participants
n=7 Participants
|
32.0 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
4 Lesions
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17.0 participants
n=5 Participants
|
|
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions
>=5 Lesions
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
pTx: Primary Tumor Cannot be Assessed
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
pT0: No Evidence of Primary Tumor
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
pTa: Noninvasive Papillary Carcinoma
|
93 participants
n=5 Participants
|
88 participants
n=7 Participants
|
181.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
pT1: Tumor Invades Subepithelial Connective Tissue
|
31 participants
n=5 Participants
|
36 participants
n=7 Participants
|
67.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
>=pT2: Tumor Invades Wider Area
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
Cis: Carcinoma in situ ("Flat Tumor")
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
No Malignancy
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43.0 participants
n=5 Participants
|
|
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage
Unspecified
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
G1 - Well Differentiated
|
59 participants
n=5 Participants
|
66 participants
n=7 Participants
|
125.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
G2 - Moderately Differentiated
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
G3 - Poorly Differentiated
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
49.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
G4 - Undifferentiated
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
GX - Unknown
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9.0 participants
n=5 Participants
|
|
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade
Unspecified
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: This is the Full Analysis Set population and contains all randomized participants who received the single instillation of Gemcitabine or Placebo.
Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival (RFS) was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.
Outcome measures
| Measure |
Gemcitabine
n=166 Participants
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
n=162 Participants
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Recurrence-Free Survival (RFS)
|
37.2 Months
Interval 0.0 to 45.9
|
40.2 Months
Interval 0.0 to 42.2
|
SECONDARY outcome
Timeframe: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: Because median time to recurrence was not reached in placebo arm, percentages of participants without recurrence are reported as post-hoc outcome measure (see #5. Post-hoc Outcome Measure). Efficacy Eligible population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.
Time from enrollment to first confirmation of histopathological recurrence or disease progression. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: Because median time for RFS was not reached in all subgroups, patients (%) with RFS are reported as post-hoc outcome #6. There was no statistically significant difference between treatment arms in any subgroup. Population consists of randomized patients with histopathologically confirmed papillary superficial transitional cell carcinoma of bladder.
Defined as the time from study enrollment to the date of the first procedure confirming histopathological recurrence or disease progression or death from any cause. Recurrence-free survival was censored at the date of the last follow-up visit for participants who were still alive and who had no recurrence/progression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: Efficacy Eligible population consists of the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.
Tumor recurrence type (superficial, stage pTA or pT1; or muscle-invasive, stage≥pT2) was classified according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer (AJCC Cancer Staging Manual, 6th edition).
Outcome measures
| Measure |
Gemcitabine
n=124 Participants
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
n=124 Participants
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Tumor Recurrence Type
No Tumor Recurrence
|
76 participants
|
78 participants
|
|
Tumor Recurrence Type
Superficial Tumor - Stage pTa or pT1
|
44 participants
|
45 participants
|
|
Tumor Recurrence Type
Muscle-Invasive Tumor - Any Stage ≥pT2
|
3 participants
|
1 participants
|
|
Tumor Recurrence Type
pTx - Tumor Cannot be Assessed
|
1 participants
|
0 participants
|
POST_HOC outcome
Timeframe: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: Efficacy Eligible population contains the Full Analysis Set participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.
Because median time to recurrence was not reached, percentage of participants without event was estimated using Kaplan-Meier method. Time to recurrence was censored on date of death for patients who died, and on date of last visit for patients who were alive, without recurrence.
Outcome measures
| Measure |
Gemcitabine
n=124 Participants
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
n=124 Participants
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Percentage of Participants Without Tumor Recurrence
Recurrence-Free at 12 Months
|
78.4 percentage of participants
Interval 56.4 to 74.5
|
76.9 percentage of participants
Interval 53.9 to 71.9
|
|
Percentage of Participants Without Tumor Recurrence
Recurrence-Free at 24 Months
|
66.3 percentage of participants
|
63.7 percentage of participants
|
POST_HOC outcome
Timeframe: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months)Population: Efficacy Eligible population consists of the Full Analysis Set (randomized) participants with histopathologically confirmed papillary superficial transitional cell carcinoma of the bladder.
RFS rate was estimated using Kaplan-Meier method. RFS was analyzed in different subgroups based on risk, disease status, and concomitant Bacillus Calmette-Guerin (BCG) instillations. Risk: Grading (G1,G2,G3) was performed according to American Joint Committee on Cancer Staging Criteria for Bladder Cancer. Newly diagnosed disease: Initial diagnosis at study entry. Recurrent disease: history of at least one superficial bladder tumor that was surgically treated and relapsed prior to study entry. With BCG: received at least one instillation of BCG during study. Without BCG: didn't receive BCG.
Outcome measures
| Measure |
Gemcitabine
n=124 Participants
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
Placebo
n=124 Participants
Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
|
|---|---|---|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Low Risk (G1/G2) - 12 Months (N=106, N=109)
|
78.5 percentage of participants
Interval 68.9 to 85.4
|
78.4 percentage of participants
Interval 69.1 to 85.2
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Low Risk (G1/G2) - 24 Months (N=106, N=109)
|
63.9 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
High Risk (G3) - 12 Months (N=13, N=14)
|
66.7 percentage of participants
Interval 33.7 to 86.0
|
42.4 percentage of participants
Interval 13.7 to 69.1
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
High Risk (G3) - 24 Months (N=13, N=14)
|
57.1 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Newly Diagnosed Disease - 12 Months (N=94, N=98)
|
79.3 percentage of participants
Interval 69.1 to 86.4
|
79.8 percentage of participants
Interval 69.9 to 86.8
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Newly Diagnosed Disease - 24 Months (N=94, N=98)
|
65.4 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Recurrent Disease - 12 Months (N=30, N=26)
|
72.2 percentage of participants
Interval 50.4 to 85.7
|
58.9 percentage of participants
Interval 37.1 to 75.5
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Recurrent Disease - 24 Months (N=30, N=26)
|
59.5 percentage of participants
|
50.5 percentage of participants
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
With BCG - 12 Months (N=13, N=21)
|
61.5 percentage of participants
Interval 30.8 to 81.8
|
79.4 percentage of participants
Interval 54.0 to 91.7
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
With BCG - 24 Months (N=13, N=21)
|
49.2 percentage of participants
|
63.5 percentage of participants
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Without BCG - 12 Months (N=111, N=103)
|
79.9 percentage of participants
Interval 70.6 to 86.6
|
74.5 percentage of participants
Interval 64.4 to 82.1
|
|
Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months
Without BCG - 24 Months (N=111, N=103)
|
65.8 percentage of participants
|
60.1 percentage of participants
|
Adverse Events
Gemcitabine
Serious events: 17 serious events
Other events: 38 other events
Deaths: 0 deaths
Placebo
Serious events: 10 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine
n=166 participants at risk
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
|
Placebo
n=162 participants at risk
Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Infections and infestations
Pyelonephritis
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Infections and infestations
Septic shock
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Surgical and medical procedures
Cystoprostatectomy
|
0.60%
1/166 • Number of events 1
|
0.62%
1/162 • Number of events 1
|
|
Surgical and medical procedures
Urinary bladder excision
|
4.8%
8/166 • Number of events 8
|
3.1%
5/162 • Number of events 5
|
|
Vascular disorders
Aortic aneurysm
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Vascular disorders
Haemorrhage
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Vascular disorders
Hypertension
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
Other adverse events
| Measure |
Gemcitabine
n=166 participants at risk
Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
|
Placebo
n=162 participants at risk
Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Congenital, familial and genetic disorders
Double ureter
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Congenital, familial and genetic disorders
Kidney duplex
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/166 • Number of events 2
|
0.62%
1/162 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/166 • Number of events 2
|
0.62%
1/162 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/166 • Number of events 2
|
0.00%
0/162
|
|
General disorders
Catheter site pain
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
General disorders
Face oedema
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
General disorders
Hyperpyrexia
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
General disorders
Pain
|
0.00%
0/166
|
3.1%
5/162 • Number of events 5
|
|
General disorders
Pyrexia
|
1.8%
3/166 • Number of events 3
|
0.62%
1/162 • Number of events 1
|
|
Infections and infestations
Cystitis
|
1.2%
2/166 • Number of events 2
|
3.1%
5/162 • Number of events 5
|
|
Infections and infestations
Pyelonephritis
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Infections and infestations
Skin infection
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Infections and infestations
Urethritis
|
1.2%
2/166 • Number of events 2
|
0.62%
1/162 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/166
|
1.9%
3/162 • Number of events 3
|
|
Injury, poisoning and procedural complications
Post procedural nausea
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Injury, poisoning and procedural complications
Post procedural vomiting
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.4%
4/166 • Number of events 4
|
0.00%
0/162
|
|
Investigations
Body temperature increased
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/166
|
1.2%
2/162 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Nervous system disorders
Anticholinergic syndrome
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Nervous system disorders
Headache
|
1.8%
3/166 • Number of events 3
|
0.00%
0/162
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/166
|
0.62%
1/162 • Number of events 2
|
|
Psychiatric disorders
Sleep disorder
|
0.60%
1/166 • Number of events 1
|
1.9%
3/162 • Number of events 3
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Renal and urinary disorders
Bladder pain
|
3.0%
5/166 • Number of events 6
|
1.9%
3/162 • Number of events 4
|
|
Renal and urinary disorders
Bladder spasm
|
0.60%
1/166 • Number of events 1
|
2.5%
4/162 • Number of events 4
|
|
Renal and urinary disorders
Dysuria
|
0.60%
1/166 • Number of events 1
|
1.2%
2/162 • Number of events 2
|
|
Renal and urinary disorders
Haematuria
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Renal pain
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Renal and urinary disorders
Urethral stricture
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Renal and urinary disorders
Urge incontinence
|
0.60%
1/166 • Number of events 1
|
0.62%
1/162 • Number of events 1
|
|
Renal and urinary disorders
Vesical tenesmus
|
0.60%
1/166 • Number of events 1
|
0.62%
1/162 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.2%
2/166 • Number of events 2
|
0.00%
0/162
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.60%
1/166 • Number of events 1
|
0.62%
1/162 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Surgical and medical procedures
Urinary bladder excision
|
0.00%
0/166
|
0.62%
1/162 • Number of events 1
|
|
Vascular disorders
Haemorrhage
|
0.60%
1/166 • Number of events 1
|
1.2%
2/162 • Number of events 2
|
|
Vascular disorders
Hypertension
|
0.60%
1/166 • Number of events 1
|
0.00%
0/162
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 1-800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60