Trial Outcomes & Findings for A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine. (NCT NCT01302054)
NCT ID: NCT01302054
Last Updated: 2018-12-04
Results Overview
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
990 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Tolterodine
Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to \[\<=\] 50 percent change in urgency urinary incontinence \[UUI\] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
|
Fesoterodine
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Placebo
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
|
|---|---|---|---|
|
Tolterodine Open-Label Run-In Phase
STARTED
|
990
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
COMPLETED
|
611
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
NOT COMPLETED
|
379
|
0
|
0
|
|
Between Open-Label and Double Blind
STARTED
|
611
|
0
|
0
|
|
Between Open-Label and Double Blind
COMPLETED
|
609
|
0
|
0
|
|
Between Open-Label and Double Blind
NOT COMPLETED
|
2
|
0
|
0
|
|
Double-Blind Treatment Phase
STARTED
|
0
|
308
|
301
|
|
Double-Blind Treatment Phase
COMPLETED
|
0
|
281
|
255
|
|
Double-Blind Treatment Phase
NOT COMPLETED
|
0
|
27
|
46
|
Reasons for withdrawal
| Measure |
Tolterodine
Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to \[\<=\] 50 percent change in urgency urinary incontinence \[UUI\] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
|
Fesoterodine
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Placebo
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
|
|---|---|---|---|
|
Tolterodine Open-Label Run-In Phase
Lack of Efficacy
|
4
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Lost to Follow-up
|
17
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Withdrawal by Subject
|
16
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Protocol Violation
|
8
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Adverse Event
|
13
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Did Not Meet Entrance Criteria
|
314
|
0
|
0
|
|
Tolterodine Open-Label Run-In Phase
Other
|
7
|
0
|
0
|
|
Between Open-Label and Double Blind
Did Not Enter Double-Blind Phase
|
2
|
0
|
0
|
|
Double-Blind Treatment Phase
Lack of Efficacy
|
0
|
2
|
4
|
|
Double-Blind Treatment Phase
Lost to Follow-up
|
0
|
2
|
1
|
|
Double-Blind Treatment Phase
Withdrawal by Subject
|
0
|
6
|
14
|
|
Double-Blind Treatment Phase
Protocol Violation
|
0
|
3
|
6
|
|
Double-Blind Treatment Phase
Adverse Event
|
0
|
10
|
10
|
|
Double-Blind Treatment Phase
Did Not Meet Entrance Criteria
|
0
|
0
|
2
|
|
Double-Blind Treatment Phase
Other
|
0
|
4
|
9
|
Baseline Characteristics
A Clinical Study in Patients With Overactive Bladder With Leakage of Urine, to Find Out if the Medicine, Fesoterodine, Works in Those Patients Who Did Not Have Enough Response to the Medicine, Tolterodine.
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=990 Participants
Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had \<= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
|
|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
810 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
180 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set:all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Last Observation Carried Forward(LOCF) was used. N(number of participants analyzed):participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12(LOCF).
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=292 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
|
3.93 episodes per 24 hours
Standard Deviation 2.53
|
1.60 episodes per 24 hours
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full Analysis set (FAS): all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=279 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Baseline
|
3.93 episodes per 24 hours
Standard Deviation 2.53
|
3.83 episodes per 24 hours
Standard Deviation 2.52
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Change at Week 12
|
-2.32 episodes per 24 hours
Standard Deviation 2.67
|
-1.76 episodes per 24 hours
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline micturitions \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence (UUI). UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=279 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Baseline
|
12.44 micturitions per 24 hours
Standard Deviation 3.57
|
12.48 micturitions per 24 hours
Standard Deviation 3.75
|
|
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12
Change at Week 12
|
-1.94 micturitions per 24 hours
Standard Deviation 3.15
|
-1.57 micturitions per 24 hours
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. Here 'N' (number of participants analyzed): participants with baseline urgency episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to 3 divided by the total number of days that diary data was collected at that visit. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=279 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Baseline
|
11.38 episodes per 24 hours
Standard Deviation 3.98
|
11.26 episodes per 24 hours
Standard Deviation 4.01
|
|
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
Change at Week 12
|
-3.33 episodes per 24 hours
Standard Deviation 4.47
|
-2.52 episodes per 24 hours
Standard Deviation 4.45
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
PPBC: single-item, self-administered validated questionnaire. Participant answered: "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale, 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change=observation minus baseline. Results categorized as Deterioration (Positive change from baseline); No Change (scores change=0); Minor Improvement (negative score change in magnitude of 1); Major Improvement (negative score change in magnitude of \>=2).
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=291 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=267 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: No Problems at all
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: Some Very Minor Problems
|
4 participants
|
6 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: Some Minor Problems
|
15 participants
|
9 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: Some Moderate Problems
|
60 participants
|
75 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: Severe Problems
|
147 participants
|
141 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Baseline: Many Severe Problems
|
65 participants
|
36 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Change at Week 12: Deterioration
|
17 participants
|
32 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Change at Week 12: No Change
|
80 participants
|
95 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Change at Week 12: Minor Improvement
|
84 participants
|
83 participants
|
|
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12
Change at Week 12: Major Improvement
|
110 participants
|
57 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here, 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
UPS: single-item, self-administered validated questionnaire. Participant answered: "Which of the following would typically describe your experience when you have a desire to urinate?" on a 3-point scale, 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change = observation minus baseline. Results categorized as Deterioration (Negative change); no change (Score change=0); improvement (Positive change).
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=291 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=267 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Change at Week 12: Deterioration
|
17 participants
|
31 participants
|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Baseline: Not able to hold urine
|
126 participants
|
99 participants
|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Baseline:Able to hold urine until I reach a toilet
|
158 participants
|
157 participants
|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Baseline:Able to finish what I am doing
|
7 participants
|
11 participants
|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Change at Week 12: No Change
|
167 participants
|
158 participants
|
|
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12
Change at Week 12: Improvement
|
107 participants
|
78 participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (not at all) to 6 (a very great deal). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale \[(Actual total raw score - lowest possible value of raw score)/range\]\*100. Higher scores values indicative of greater symptom bother. Change=observation minus baseline.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=286 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=267 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Baseline
|
66.67 units on a scale
Standard Deviation 20.28
|
64.74 units on a scale
Standard Deviation 19.69
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12
Change at Week 12
|
-24.61 units on a scale
Standard Deviation 25.57
|
-15.99 units on a scale
Standard Deviation 24.53
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Here 'N' (number of participants analyzed): participants with non-missing change from baseline value at Week 12.
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (not at all) to 6 (a very great deal). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = \[(Highest possible raw score-Actual total raw score)/Raw score range\]\*100. Higher transformed scores indicative of better HRQL.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=286 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=267 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Concern Subscale: Baseline
|
43.63 units on a scale
Standard Deviation 26.00
|
44.25 units on a scale
Standard Deviation 25.58
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Concern Subscale: Change at Week 12
|
23.11 units on a scale
Standard Deviation 27.77
|
13.83 units on a scale
Standard Deviation 25.03
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Coping Subscale: Baseline
|
38.74 units on a scale
Standard Deviation 26.24
|
41.15 units on a scale
Standard Deviation 26.04
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Coping Subscale: Change at Week 12
|
23.70 units on a scale
Standard Deviation 26.69
|
15.07 units on a scale
Standard Deviation 24.20
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Sleep Subscale: Baseline
|
41.38 units on a scale
Standard Deviation 25.66
|
40.69 units on a scale
Standard Deviation 26.28
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Sleep Subscale: Change at Week 12
|
20.85 units on a scale
Standard Deviation 27.42
|
14.79 units on a scale
Standard Deviation 25.74
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Social Interaction Subscale: Baseline
|
65.03 units on a scale
Standard Deviation 28.34
|
68.40 units on a scale
Standard Deviation 26.29
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Social Interaction Subscale: Change at Week 12
|
14.47 units on a scale
Standard Deviation 24.26
|
8.85 units on a scale
Standard Deviation 21.12
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Total HRQL Score: Baseline
|
45.90 units on a scale
Standard Deviation 23.72
|
47.38 units on a scale
Standard Deviation 22.70
|
|
Change From Baseline in Health Related Quality of Life (HRQL) Domains and Total HRQL Score of Overactive Bladder Questionnaire (OAB-q) at Week 12
Total HRQL Score: Change at Week 12
|
21.12 units on a scale
Standard Deviation 24.62
|
13.42 units on a scale
Standard Deviation 21.92
|
SECONDARY outcome
Timeframe: Week -2, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with Week -2 UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=279 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=275 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Week -2
|
72.8 percentage of participants
|
59.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 12 (LOCF).
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=279 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Percentage of Participants With More Than (>) 50 Percent (%) Reduction in UUI Episodes at Week 12 as Compared to Baseline
|
69.9 percentage of participants
|
57.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, Week 12Population: FAS: all randomized participants who received at least 1 dose of double-blind study treatment, had baseline/post-baseline efficacy assessment. Missing data were imputed by LOCF. N (number of participants analyzed): participants with baseline UUI episodes \>0 per 24 hours and non-missing change from baseline at Week 4 and 12 (LOCF).
UUI episodes were defined as those with the urinary sensation scale (USS) rating of 5 in the diary. USS range from 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Outcome measures
| Measure |
Fesoterodine: Double-Blind Baseline
n=292 Participants
Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Fesoterodine: Double-Blind Week 12
n=279 Participants
Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
|---|---|---|
|
Percentage of Participants With No UUI Episodes (Diary Dry Rate)
Week 4
|
25.4 percentage of participants
|
17.7 percentage of participants
|
|
Percentage of Participants With No UUI Episodes (Diary Dry Rate)
Week 12
|
39.0 percentage of participants
|
32.3 percentage of participants
|
Adverse Events
Tolterodine
Serious events: 3 serious events
Other events: 90 other events
Deaths: 0 deaths
Fesoterodine
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tolterodine
n=990 participants at risk
Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to \[\<=\] 50 percent change in urgency urinary incontinence \[UUI\] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
|
Fesoterodine
n=308 participants at risk
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Placebo
n=301 participants at risk
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.10%
1/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.10%
1/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.33%
1/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Arterial occlusive disease
|
0.10%
1/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Tolterodine
n=990 participants at risk
Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to \[\<=\] 50 percent change in urgency urinary incontinence \[UUI\] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
|
Fesoterodine
n=308 participants at risk
Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
|
Placebo
n=301 participants at risk
Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.10%
1/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.97%
3/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
11/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
3.9%
12/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
4/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.65%
2/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
6.2%
61/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
16.6%
51/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
4.0%
12/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.20%
2/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.9%
6/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.71%
7/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
3/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
3/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.61%
6/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.97%
3/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.30%
3/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.65%
2/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
3/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
3/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
3/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.00%
3/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.10%
1/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.32%
1/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.40%
4/990
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.97%
3/308
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
1.3%
4/301
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER