A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01302067

Collaborator

(none)

2,012

Enrollment

293

Locations

Arms

18.1

Duration (Months)

6.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Fesoterodine 8mg Drug: Fesoterodine 4mg Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

2012 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A 12-Week, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine.

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine 8mg	Drug: Fesoterodine 8mg Oral, 1 tablet per day, 12 weeks duration, 8mg/day
Experimental: Fesoterodine 4mg	Drug: Fesoterodine 4mg Oral, 1 tablet per day, 12 weeks duration, 4mg/day
Placebo Comparator: Placebo	Drug: Placebo Oral, 1 tablet per day, 12 weeks duration

Arm

Intervention/Treatment

Experimental: Fesoterodine 8mg

Drug: Fesoterodine 8mg

Oral, 1 tablet per day, 12 weeks duration, 8mg/day

Experimental: Fesoterodine 4mg

Drug: Fesoterodine 4mg

Oral, 1 tablet per day, 12 weeks duration, 4mg/day

Placebo Comparator: Placebo

Drug: Placebo

Oral, 1 tablet per day, 12 weeks duration

Outcome Measures

Primary Outcome Measures

Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. [Week 12]
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 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.

Secondary Outcome Measures

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4. [Week 4]
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12. [Week 12]
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4. [Week 4]
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12. [Week 12]
Micturitions include episodes of voluntary micturition and episodes of UUI.
Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4. [Week 4]
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4. [Week 4]
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12. [Week 12]
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. [Week 4]
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 total range 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.
Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. [Week 12]
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 total range 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.
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4. [Week 4]
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 total range 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.
Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12. [Week 12]
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 total range 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.
Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12. [Week 12]
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12. [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).
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12. [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 From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [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.
Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [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.
Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [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.
Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [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.
Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12. [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.
Percentage of Participants Who Became Dry at Week 4. [Week 4]
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Percentage of Participants Who Became Dry at Week 12. [Week 12]
Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

6 months overactive bladder symptoms, minimum of 2 urgency urinary incontinence episodes per 24 hours and minimum of 8 micturitions per 24 hours.

Exclusion Criteria:

Other concurrent and concomitant medication or disease that could put the subjects at additional risk or interfere with the study results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology Centers of Alabama	Birmingham	Alabama	United States	35209
2	Achieve Clinical Research, LLC	Birmingham	Alabama	United States	35216
3	James Gordon McMurray, MD	Huntsville	Alabama	United States	35801
4	Medical Affiliated Research Center, Inc.	Huntsville	Alabama	United States	35801
5	Mobile Ob-Gyn, P.C.	Mobile	Alabama	United States	36608
6	Montgomery Women's Health Associates, P.C.	Montgomery	Alabama	United States	36117
7	Scottsboro Quick Care Clinic	Scottsboro	Alabama	United States	35768
8	Dedicated Clinical Research	Phoenix	Arizona	United States	85020
9	Genova Clinical Research	Tucson	Arizona	United States	85704
10	NEA Baptist Women's Clinic	Jonesboro	Arkansas	United States	72401
11	A Clinic For Women	Little Rock	Arkansas	United States	72205
12	Larry S. Watkins, MD	Little Rock	Arkansas	United States	72205
13	Lynn Institute of the Ozarks	Little Rock	Arkansas	United States	72205
14	May Women's Health Clinic	Little Rock	Arkansas	United States	72205
15	The Office of Dr. Simon Yassear, MD	Carmichael	California	United States	95608
16	Citrus Valley Medical Research, Inc.	Glendora	California	United States	91741
17	Grossmont Center for Clinical Research	La Mesa	California	United States	91942
18	Sockolov and Sockolov APC	Sacramento	California	United States	95825
19	Genesis Center for Clinical Research	San Diego	California	United States	92103
20	San Diego Clinical Trials	San Diego	California	United States	92120
21	Clinical Innovations, Inc.	Santa Ana	California	United States	92705
22	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
23	Urology Associates, PC	Denver	Colorado	United States	80113
24	Genitourinary Surgical Consultants	Denver	Colorado	United States	80220
25	The Women's Clinic of Northern Colorado	Fort Collins	Colorado	United States	80524
26	Women's Health Specialty Care	Farmington	Connecticut	United States	06032
27	South Florida Medical Research	Aventura	Florida	United States	33180
28	Uromedix	Aventura	Florida	United States	33180
29	Meridien Research	Bradenton	Florida	United States	34208
30	Florida Sleep Disorder Center of Brandon	Brandon	Florida	United States	33511
31	PAB Clinical Research	Brandon	Florida	United States	33511
32	Pulmonary Associates of Brandon	Brandon	Florida	United States	33511
33	Meridien Research	Brooksville	Florida	United States	34601
34	Nature Coast Clinical Research	Crystal River	Florida	United States	34429
35	Doctors Medical Center of Walton County	DeFuniak Springs	Florida	United States	32435
36	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
37	SJS Clinical Research, Inc.	Destin	Florida	United States	32541
38	Fleming Island Center for Clinical Research	Fleming Island	Florida	United States	32003
39	M & O Clinical Research, LLC	Fort Lauderdale	Florida	United States	33316
40	Florida Urology Physicians	Fort Myers	Florida	United States	33908
41	Urological Research Network, LLC	Hialeah	Florida	United States	33016
42	Nature Coast Clinical Research	Inverness	Florida	United States	34452
43	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
44	Altus Research	Lake Worth	Florida	United States	33461
45	OB-GYN Associates of Mid-Florida, PA	Leesburg	Florida	United States	34748
46	New Horizon Research Center	Miami	Florida	United States	33175
47	Urology Health Team, PLLC	Ocala	Florida	United States	34474
48	Broward Research Group	Pembroke Pines	Florida	United States	33026
49	Clinical Research of Central Florida	Plant City	Florida	United States	33563
50	Southeastern Research Group, Inc.	Tallahassee	Florida	United States	32308
51	Meridien Research	Tampa	Florida	United States	33606
52	Advanced OBGYN Associates	West Palm Beach	Florida	United States	33409
53	Clinical Research of Central Florida	Winter Haven	Florida	United States	33880
54	North Fulton Urology, PC	Roswell	Georgia	United States	30076
55	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
56	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
57	North Georgia Internal Medicine	Woodstock	Georgia	United States	30189
58	Women's Healthcare Associates dba Rosemark WomenCare Specialists	Idaho Falls	Idaho	United States	83404
59	Advanced Clinical Research	Meridian	Idaho	United States	83642
60	Women's Health Practice	Champaign	Illinois	United States	61820
61	Center for Women's Research	Chicago	Illinois	United States	60612
62	Medical and Surgical Specialists	Galesburg	Illinois	United States	61401
63	Clinical Investigation Specialists, Inc.	Gurnee	Illinois	United States	60031
64	American Health Network of Indiana, LLC	Avon	Indiana	United States	46123
65	Summit Research Institute	Bloomington	Indiana	United States	47403
66	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
67	American Health Network of Indiana, LLC	Greenfield	Indiana	United States	46140
68	Metropolitan Urology	Jeffersonville	Indiana	United States	47130
69	Deaconess Clinic Gateway Health Center	Newburgh	Indiana	United States	47630
70	University of Iowa Healthcare	Iowa City	Iowa	United States	52242
71	Health Science Research Center	Pratt	Kansas	United States	67124
72	Women's and Family Care dba GTC Research	Shawnee	Kansas	United States	66218
73	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
74	Kentucky Medical Research Center	Lexington	Kentucky	United States	40504
75	Commonwealth Biomedical Research	Madisonville	Kentucky	United States	42431
76	Central Kentucky Research Associates, Inc.	Mount Sterling	Kentucky	United States	40353
77	Mount Sterling Clinic	Mount Sterling	Kentucky	United States	40353
78	The Office of Dr. Myron I. Murdock, MD, LLC	Greenbelt	Maryland	United States	20770
79	Boston Clinical Trials, Inc.	Boston	Massachusetts	United States	02135
80	Beacon Clinical Research, LLC	Brockton	Massachusetts	United States	02301
81	Clinical Research Center of Cape Cod, Inc.	Hyannis	Massachusetts	United States	02601
82	Infinity Medical Research	North Dartmouth	Massachusetts	United States	02747
83	DM Clinical Research	Springfield	Massachusetts	United States	01103
84	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	United States	48047
85	CRC of Jackson	Jackson	Mississippi	United States	39202
86	Mississippi Urology Clinic	Jackson	Mississippi	United States	39202
87	Mercy Health Research	St. Louis	Missouri	United States	63141
88	Midwest Pharmaceutical Research	St. Peters	Missouri	United States	63376
89	Family Health Care Center	Lincoln	Nebraska	United States	68506
90	Women's Clinic of Lincoln, P.C.	Lincoln	Nebraska	United States	68510
91	Lincoln Internal Medicine Associates	Lincoln	Nebraska	United States	68516
92	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89123
93	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89130
94	Virtua Phoenix Ob-Gyn	Moorestown	New Jersey	United States	08057
95	Premier Research, Inc.	Trenton	New Jersey	United States	08611
96	United Medical Associates	Binghamton	New York	United States	13901
97	Brooklyn Urology Research Group	Brooklyn	New York	United States	11215
98	Urological Surgeons of Long Island	Garden City	New York	United States	11530
99	Premier Medical Group of the Hudson Valley	Kingston	New York	United States	12401
100	Mid Hudson Medical Research, PLLC	New Windsor	New York	United States	12553
101	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York	United States	12601
102	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
103	Kernodle Clinic, Inc.	Burlington	North Carolina	United States	27215
104	American Health Research	Charlotte	North Carolina	United States	28207
105	Carolina Clinical Trials	Concord	North Carolina	United States	28025
106	Carolina Urology Partners, PLLC	Concord	North Carolina	United States	28025
107	Carolinas Research Associates	Harrisburg	North Carolina	United States	28075
108	University Medical Associates	Huntersville	North Carolina	United States	28078
109	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
110	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
111	PMG Research of Wilmington, LLC	Wilmington	North Carolina	United States	28401
112	Hawthorne Medical Research, Inc. - Hawthorne OB/GYN Associates	Winston-Salem	North Carolina	United States	27103
113	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina	United States	27103
114	Patient Priority Clinical Sites, LLC	Cincinnati	Ohio	United States	45215
115	Rapid Medical Research, Inc.	Cleveland	Ohio	United States	44122
116	Columbus Center for Women's Health Research	Columbus	Ohio	United States	43213
117	Columbus Clinical Research	Columbus	Ohio	United States	43213
118	Hometown Urgent Care and Research	Dayton	Ohio	United States	45432
119	HWC Women's Research Center	Englewood	Ohio	United States	45322
120	Ohio Clinical Research, LLC	Willoughby Hills	Ohio	United States	44094
121	The Office of Johnny B. Roy, MD	Edmond	Oklahoma	United States	73034
122	Legacy Clinical Research, LLC	Oklahoma City	Oklahoma	United States	73109
123	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
124	Institute for Female Pelvic Medicine	Allentown	Pennsylvania	United States	18103
125	Laurel Highlands OB/GYN	Hopwood	Pennsylvania	United States	15445
126	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania	United States	19046
127	Richard Kastelic and Associates	Johnstown	Pennsylvania	United States	15405
128	Clinical Trials Research Services, LLC	Pittsburgh	Pennsylvania	United States	15206
129	Triangle Urological Group	Pittsburgh	Pennsylvania	United States	15212
130	Mount Nittany Medical Center Health Services Inc. dba Mount Nittany Physician Group	State College	Pennsylvania	United States	16801
131	Pish Medical Associates	Uniontown	Pennsylvania	United States	15401
132	Advanced Clinical Concepts	West Reading	Pennsylvania	United States	19611
133	Woman's Clinic Ltd.	West Reading	Pennsylvania	United States	19611
134	Coastal Medical	East Greenwich	Rhode Island	United States	02818
135	Safe Harbor Clinical Research	East Providence	Rhode Island	United States	02914
136	Omega Medical Research	Warwick	Rhode Island	United States	02886
137	TLM Medical Services, LLC	Columbia	South Carolina	United States	29204
138	Coastal Carolina Research Center	Mt. Pleasant	South Carolina	United States	29464
139	Southern Urogynecology	West Columbia	South Carolina	United States	29169
140	Internal Medicine and Pediatric Associates of Bristol, PC	Bristol	Tennessee	United States	37620
141	PMG Research of Bristol, LLC	Bristol	Tennessee	United States	37620
142	Adams Patterson Gynocology and Obstetrics, PLLC	Memphis	Tennessee	United States	38120
143	Heartland Medical PC	New Tazewell	Tennessee	United States	37825
144	Austin Center for Clinical Research	Austin	Texas	United States	78756
145	RJE Clinical Research	Dallas	Texas	United States	75224
146	Memorial Clinical Associates dba MCA Research	Houston	Texas	United States	77079
147	ACRC Trials (Administrative/Mailing Site)	Plano	Texas	United States	75024
148	North Texas Family Medicine	Plano	Texas	United States	75093
149	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
150	Institute for Women's Health	San Antonio	Texas	United States	78229
151	Seven Oaks Women's Center	San Antonio	Texas	United States	78229
152	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78299
153	Scott and White Healthcare	Temple	Texas	United States	76502
154	Scott and White Healthcare	Temple	Texas	United States	76508
155	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
156	National Clinical Research - Richmond	Richmond	Virginia	United States	23294
157	Independence Family Medicine	Virginia Beach	Virginia	United States	23455
158	Seattle Urology Research Center	Burien	Washington	United States	98166
159	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
160	CAMC Physicians Group	Charleston	West Virginia	United States	25304
161	Charleston Internal Medicine, Inc.	Charleston	West Virginia	United States	25304
162	Urologic Surgical Center	Charleston	West Virginia	United States	25304
163	Clinical Investigation Specialists, Inc.	Kenosha	Wisconsin	United States	53142
164	Dean Oregon Clinic	Oregon	Wisconsin	United States	53575
165	Allegiance Research Specialists	Wauwatosa	Wisconsin	United States	53226
166	Instituto Urologico Buenos Aires	Buenos Aires		Argentina	C1060AAA
167	Centro de Urología (CDU)	Buenos Aires		Argentina	C1120AAS
168	Instituto Medico Especializado (IME)	Buenos Aires		Argentina	C1405BCH
169	Office of Dr. Peter Pommerville	Victoria	British Columbia	Canada	V6T 5G1
170	Can-Med Clinical Research	Victoria	British Columbia	Canada	V8R 6T9
171	Office of Dr. Nazmuddin Merali	Victoria	British Columbia	Canada	V8R 6T9
172	Can-Med Clinical Research Incorporated	Victoria	British Columbia	Canada	V8T 5G1
173	Pharos Medical Research Ltd.	Grand Falls-Windsor	Newfoundland and Labrador	Canada	A2A 2E2
174	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 3A7
175	McMaster Institute of Urology, St Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N 4A6
176	Office of Dr. Bernard Goldfarb	North Bay	Ontario	Canada	P1B 7K8
177	Stanley Flax Medical Professional Corporation	North York	Ontario	Canada	M2J 1V1
178	Urotec	Oshawa	Ontario	Canada	L1H 7K4
179	Toronto Western Hospital, University Health Network	Toronto	Ontario	Canada	M5T 2S8
180	Toronto Urology Clinical Study Group	Toronto	Ontario	Canada	M6A 3B5
181	Urology South Shore Research	Greenfield Park	Quebec	Canada	J4V 2H3
182	UroLaval	Laval	Quebec	Canada	H7G 2E6
183	Ultra-Med Inc.	Pointe-Claire	Quebec	Canada	H9R 4S3
184	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
185	Clinica Uromed	Santiago	RM	Chile	7500787
186	Hospital Clinico Universidad de Chile	Santiago	RM	Chile	8380456
187	Fundacion Centro de Investigacion Clinica CIC	Medellin	Antioquia	Colombia	0000
188	Solano Y Terront Servicios Medicos Ltda / Unidad Integral de Endocrinologia Uniendo	Bogota	Cundinamarca	Colombia	0000
189	Urologicka ambulance	Benesov		Czech Republic	25601
190	FN a LFUK Hradec Kralove/Urologicka klinika	Hradec Kralove		Czech Republic	500 05
191	Nemocnice Jablonec nad Nisou	Jablonec nad Nisou		Czech Republic	466 60
192	Urologicka klinika	Praha 1 - Nove Mesto		Czech Republic	110 00
193	Fakultni nemocnice v Motole	Praha 5		Czech Republic	15006
194	Androgeos spol. s.r.o.	Praha 6 - Hradcany		Czech Republic	160 00
195	Urologicka ambulance	Znojmo		Czech Republic	66902
196	Herlev Hospital	Herlev		Denmark	2730
197	Roskilde sygehus, Gynaekologisk/obstetrisk afdeling	Roskilde		Denmark	4000
198	Al-Azhar University hospital	Cairo		Egypt
199	Kouvolan Lääkäriasema	Kouvola		Finland	45200
200	Lääkäriasema Cantti Oy	Kuopio		Finland	70110
201	Hôpital Edouard Herriot	Lyon Cedex 03		France	69437
202	CHU de Nantes - Hôtel Dieu	Nantes		France	44093
203	Hôpital CAREMEAU - Service Urologie/Andrologie	Nimes Cedex 9		France	30029
204	Hôpital Tenon - Service d'Urologie	Paris		France	75020
205	Arztpraxis	Alzey		Germany	55232
206	Synexus Clinical Research GmbH	Berlin		Germany	12627
207	Klinische Forschung Berlin-Buch GmbH	Berlin		Germany	13125
208	Synexus Clinical Research GmbH	Bochum		Germany	44787
209	Klinische Forschung Dresden GmbH	Dresden		Germany	01069
210	Synexus Clinical Research GmbH	Frankfurt am Main		Germany	60596
211	Synexus Clinical Research GmbH	Goerlitz		Germany	02826
212	Clinical Research Hamburg	Hamburg		Germany	22143
213	Klinische Forschung Hannover - Mitte GmbH	Hannover		Germany	30159
214	Allgemeinmedizin Praktische Aerzte	Karlsruhe		Germany	76199
215	Arztpraxis	Lauenburg		Germany	21481
216	Synexus Clinical Research GmbH	Leipzig		Germany	04103
217	SMO MD GmbH	Magdeburg		Germany	39112
218	CRS Clinical Research Service Moenchengladbach GmbH	Moenchengladbach		Germany	41061
219	Praxisklinik Urologie Rhein-Ruhr	Muelheim a.d. Ruhr		Germany	45468
220	Facharzt fuer Urologie	Reutlingen		Germany	72764
221	Klinische Forschung Schwerin GmbH	Schwerin		Germany	19055
222	University General Hospital of Larisa/ Urology Department	Larisa		Greece	41110
223	General Hospital Papageorgiou	Thessaloniki		Greece	56429
224	Synexus Magyarorszag Kft.	Budapest		Hungary	1036
225	Jahn Ferenc Del-pesti Korhaz, Urologiai Osztaly	Budapest		Hungary	1204
226	Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Urologiai Klinika	Debrecen		Hungary	4032
227	Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Urologiai osztaly	Nyiregyhaza		Hungary	4400
228	Università Magna Graecia di Catanzaro	Catanzaro		Italy	88100
229	Clinica Urologica Centro Trapianti di rene	Foggia		Italy	71122
230	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
231	Severance Hospital, Yonsei University College of Medicine, Department of Urology	Seoul		Korea, Republic of	120-752
232	Samsung Medical Center	Seoul		Korea, Republic of	135-710
233	Department of Urology, Korea University Anam Hospital	Seoul		Korea, Republic of	136-705
234	The Catholic University of Korea Seoul St. Mary's Hospital, Department of Urology	Seoul		Korea, Republic of	137-701
235	Asan Medical Center, Department of Urology	Seoul		Korea, Republic of	138-736
236	Saules Seimos Medicinos Centras, JSC	Kaunas		Lithuania	49449
237	Mano Seimos Gydytojas, JSC	Klaipeda		Lithuania	94231
238	Seimos Gydytojas, JSC	Vilnius		Lithuania	01118
239	Hospital Lomas de San Luis Internacional	San Luis Potosi		Mexico	78218
240	Medi 3 Elverum AS	Elverum		Norway	2408
241	Medi 3 Innlandet	Hamar		Norway	2317
242	Norsk Helseklinikk AS, c/o Heiaklinikken	Lierskogen		Norway	3420
243	Forusakutten AS, Avdeling for oppdragsforskning	Stavanger		Norway	4005
244	Perpetual Succour Hospital of Cebu Inc.	Cebu City	Cebu	Philippines	6000
245	Dr. Pablo O. Torre Memorial Hospital	Bacolod City		Philippines	6100
246	St. Paul's Hospital	Iloilo City		Philippines	5000
247	Klinika Urologii Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdansku	Gdansk		Poland	80-402
248	NZOZ Centrum Medyczne	Lodz		Poland	90-302
249	Centrum Urologiczne Sp. z o. o.	Myslowice		Poland	41-400
250	Nzoz "Nasz Lekarz"	Torun		Poland	87-100
251	Non-governmental Healthcare Institution Departmental Clinical Hospital at Barnaul station OAO RZD	Barnaul		Russian Federation	656038
252	Rostov State Medical University, Chair of Urology	Rostov-on-Don		Russian Federation	344022
253	Research Institute of Obstetrics and Gynaecology D.O. Otta of North-west Department of RAMS	Saint-Petersburg		Russian Federation	199034
254	URO CLINIC, s.r.o.	Bratislava		Slovakia	811 06
255	Ruzinovska poliklinika, a.s.	Bratislava		Slovakia	820 07
256	Nemocnica s Poliklinikou Svateho Lukasa Galanta	Galanta		Slovakia	924 22
257	UROX s.r.o.	Piestany		Slovakia	921 01
258	Centrum urologie Povazska Bystrica, s.r.o. urologicka ambulancia	Povazska Bystrica		Slovakia	017 01
259	Fakultna nemocnica Trencin	Trencin		Slovakia	911 71
260	UROGYN,s.r.o.	Zilina		Slovakia	010 01
261	Fakultna nemocnica s poliklinikou Zilina	Zilina		Slovakia	012 07
262	GYNPOR SK, s.r.o. Urogynekologicka ambulancia	Zvolen		Slovakia	960 01
263	Clinical Research Unit	Pretoria	Gauteng	South Africa	0001
264	Clinix Private Clinic	Vosloorus	Gauteng	South Africa	1475
265	Mayo Centre	Roodepoort		South Africa	1715
266	Carema Specialistvard Eslov	Eslov		Sweden	241 23
267	Hagakliniken	Goteborg		Sweden	413 28
268	CTC, Sahlgrenska sjukhuset/SU	Goteborg		Sweden	413 45
269	Probare	Lund		Sweden	222 22
270	Center for Lakemedelsstudier	Malmo		Sweden	211 52
271	Ladulaas kliniska studier	Skene		Sweden	511 62
272	Verksamhet Urologi	Skovde		Sweden	541 85
273	Kvinnokliniken Karolinska Universitetssjukhuset Huddinge	Stockholm		Sweden	141 86
274	S3 Clinical Research Centers	Vallingby		Sweden	162 68
275	Vasterviks sjukhus, Kvinnokliniken	Vastervik		Sweden	593 81
276	Chang Gung Medical Foundation. Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan	833
277	National Taiwan University Hospital, Department of Urology	Taipei		Taiwan	100
278	Taipei Veterans General Hospital/Division of Urology	Taipei		Taiwan	112
279	RMI "Chernivtsi Regional Clinical Hosp.", Dep. of Urology, BSMU, Chair of Surgery and Urology	Chernivtsi		Ukraine	58002
280	City Hospital #4 of Donetsk, Woman Consultative Department	Donetsk		Ukraine	83002
281	Department of Urology of Donetsk National Medical University at Central City Clinical Hospital #1	Donetsk		Ukraine
282	MTPI "Central City Clinical Hospital #1"/Donetsk National Medical University n.a. M. Gorkiy,	Donetsk		Ukraine
283	Uzhorod City Outpatient Clinic, Prophylaxis Department	Uzhorod		Ukraine	88000
284	Vinnitsa Regional Clinical Dispensary of Endocrinology	Vinnitsa		Ukraine	21010
285	Urology Dept of Zaporizhzhia Medical Academy of Postgraduate Education	Zaporizhzhia		Ukraine	69600
286	Fowey River Practice	Fowey	Cornwall	United Kingdom	PL23 1DT
287	Knowle House Surgery	Plymouth	Devon	United Kingdom	PL5 3JB
288	Ormeau Health Centre	Belfast	Northern Ireland	United Kingdom	BT7 2EB
289	Cambridge University Hospital Trials NHS Trust	Cambridge		United Kingdom	CB2 2QQ
290	Southern General Hospital	Glasgow		United Kingdom	G51 4TF
291	Baillieston Health Centre	Glasgow		United Kingdom	G69 7AD
292	Sheepcot Medical Centre	Hertfordshire		United Kingdom	WD2 6EB
293	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01302067

Other Study ID Numbers:

A0221095
EIGHT

First Posted:

Feb 23, 2011

Last Update Posted:

Mar 26, 2014

Last Verified:

Feb 1, 2014

Additional relevant MeSH terms:

Urinary Bladder, Overactive

Fesoterodine

Study Results

Participant Flow

Recruitment Details	This report presents results of a 12-week study conducted at 241 centers across 27 countries.
Pre-assignment Detail	Participants ≥18 years of age with overactive bladder (OAB) symptoms for ≥6 months prior to screening were enrolled. After screening eligible participants were enrolled into the run-in period and received placebo for 2 weeks in a single-blind manner. Participants completed a 3-day bladder diary for 3 days in the week prior to randomization.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Period Title: Overall Study
STARTED	790	386	779
COMPLETED	712	352	681
NOT COMPLETED	78	34	98

Baseline Characteristics

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg	Total
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.	Total of all reporting groups
Overall Participants	790	386	779	1955
Age, Customized (Years) [Number]
<18	0	0	0	0
18 to 44	114	49	99	262
45 to 64	380	193	377	950
>= 65	296	144	303	743
Sex: Female, Male (Count of Participants)
Female	647 81.9%	316 81.9%	627 80.5%	1590 81.3%
Male	143 18.1%	70 18.1%	152 19.5%	365 18.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12.
Description	UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
Full Analysis Set (FAS)included participants receiving 1 dose of assigned study drug and with 1 baseline (BL) or post-BL efficacy assessment. Last observation carried forward (LOCF) was used to impute missing data at Week 12. Participants with baseline UUI >0 per 24 hours & non-missing change from BL to Week 12 were included.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	718
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-2.85 (0.09)	-2.22 (0.12)	-3.12 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	Comparisons were done with 2-sided test at 5% significance level. Null hypothesis: mean change from BL in the number of UUI episodes per 24 hours in the 8mg group was same as 4mg group at Week 12. ANCOVA was used to compare 8mg and 4mg arms for numeric change from BL - Week 12. This included terms for treatment, country, centered BL value and centered BL by treatment interaction, in which centered BL (BL - mean BL) was used to ensure that treatment effect was estimated at mean covariate value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Primary comparison was 8 mg VS. 4 mg (closed-testing method). Treatment effect of 8 mg VS. placebo was tested 1st. Treatment difference of 8 mg VS. 4 mg was tested if a statistically significant difference between 8 mg and placebo was shown.
	Method	ANCOVA
	Comments	Using a closed testing procedure, no adjustments of α-level was needed at each stage of testing. Each was done at the 0.05 significance level.

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.91
	Confidence Interval	(2-Sided) 95% -1.16 to -0.66
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	Treatment comparisons were performed with a two-sided test at the 5% significance level.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0109
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95% -0.48 to -0.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	Treatment comparisons were performed with a two-sided test at the 5% significance level.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95% -0.89 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

2. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4.
Description	Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	705
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-1.95 (0.13)	-1.19 (0.16)	-2.33 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95% -1.48 to -0.79
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0082
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 95% -0.67 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.14
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.75
	Confidence Interval	(2-Sided) 95% -1.10 to -0.41
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.18
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

3. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12.
Description	Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	719
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-2.45 (0.13)	-1.58 (0.17)	-2.97 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.40
	Confidence Interval	(2-Sided) 95% -1.76 to -1.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.53
	Confidence Interval	(2-Sided) 95% -0.83 to -0.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.15
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95% -1.23 to -0.51
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.19
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

4. Secondary Outcome

Title	Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 4.
Description	Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	705
Median (Full Range) [Episodes per 24 hours]	-14.58	-9.01	-17.24

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0040
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

5. Secondary Outcome

Title	Change From Baseline in Percentage of Micturitions Per 24 Hours at Week 12.
Description	Micturitions include episodes of voluntary micturition and episodes of UUI.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition Frequency >0 per 24 hours and non-missing change from BL to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	719
Median (Full Range) [Episodes per 24 hours]	-19.74	-12.16	-24.14

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

6. Secondary Outcome

Title	Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 4.
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	704
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-2.55 (0.09)	-1.99 (0.12)	-2.75 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95% -1.02 to -0.50
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0662
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95% -0.41 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.11
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.56
	Confidence Interval	(2-Sided) 95% -0.82 to -0.30
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.13
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

7. Secondary Outcome

Title	Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 4.
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	704
Median (Full Range) [Episodes per 24 hours]	-77.78	-60.50	-82.48

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant

8. Secondary Outcome

Title	Change From Baseline in Percentage of UUI Episodes Per 24 Hours at Week 12.
Description	UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL UUI >0 per 24 hours and non-missing change from BL to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	718
Median (Full Range) [Episodes per 24 hours]	-93.75	-78.89	-100.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant

9. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
Description	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 total range 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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-related urgency episodes >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	705
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-2.89 (0.18)	-1.85 (0.23)	-3.40 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.55
	Confidence Interval	(2-Sided) 95% -2.04 to -1.06
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.25
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0121
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.52
	Confidence Interval	(2-Sided) 95% -0.92 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.21
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.04
	Confidence Interval	(2-Sided) 95% -1.52 to -0.55
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.25
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

10. Secondary Outcome

Title	Change From Baseline in Mean Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
Description	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 total range 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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	719
Least Squares Mean (Standard Error) [Episodes per 24 hours]	-4.23 (0.19)	-2.99 (0.25)	-5.01 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-2.02
	Confidence Interval	(2-Sided) 95% -2.55 to -1.49
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-0.78
	Confidence Interval	(2-Sided) 95% -1.22 to -0.34
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.22
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, and centered baseline value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 95% -1.77 to -0.71
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.27
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

11. Secondary Outcome

Title	Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 4.
Description	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 total range 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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	705
Median (Full Range) [Participant]	-23.26	-14.70	-27.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0348
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

12. Secondary Outcome

Title	Change From Baseline in Percentage of Micturition-Related Urgency Episodes Per 24 Hours at Week 12.
Description	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 total range 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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. LOCF was used to impute missing data at Week 12. The analysis included participants with BL Micturition-Related Urgency Episodes >0 per 24 hours and non-missing change from BL to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	719
Median (Full Range) [Participant]	-34.88	-22.73	-44.29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on a RANKED ANCOVA model with terms for treatment and pooled country with ranked baseline value as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments	Testing for percent change from baseline was only carried out for given endpoint if corresponding numeric change result was statistically significant.

13. Secondary Outcome

Title	Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 12.
Description	PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Improvement is defined as negative change from baseline.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	700	348	677
Deterioration	38 4.8%	25 6.5%	27 3.5%
No Change	172 21.8%	122 31.6%	151 19.4%
Minor improvement	210 26.6%	105 27.2%	170 21.8%
Major improvement	280 35.4%	96 24.9%	329 42.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0057
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0008
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

14. Secondary Outcome

Title	Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) at Week 12.
Description	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).
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	700	348	677
Deterioration	37 4.7%	23 6%	30 3.9%
No change	361 45.7%	193 50%	305 39.2%
Improvement	302 38.2%	132 34.2%	342 43.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0007
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0091
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	Change at Week 12- deterioration, no change, minor improvement and major improvement: Cochran-Mantel-Haenszel (CMH) test with modified ridit scoring controlling for country was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3901
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

15. Secondary Outcome

Title	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from baseline value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	678
Least Squares Mean (Standard Error) [Scores on a scale]	-30.19 (1.09)	-22.41 (1.43)	-34.88 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-12.47
	Confidence Interval	(2-Sided) 95% -15.49 to -9.45
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.54
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-4.69
	Confidence Interval	(2-Sided) 95% -7.15 to -2.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.26
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	Change at Week 12- ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction was used to calculate p-value.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	-7.78
	Confidence Interval	(2-Sided) 95% -10.78 to -4.78
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.53
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

16. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL)-Coping Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	677
Least Squares Mean (Standard Error) [Scores on a scale]	26.69 (1.18)	20.91 (1.55)	31.38 (1.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	10.46
	Confidence Interval	(2-Sided) 95% 7.20 to 13.73
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.67
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.68
	Confidence Interval	(2-Sided) 95% 2.01 to 7.36
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.36
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.78
	Confidence Interval	(2-Sided) 95% 2.53 to 9.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.66
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

17. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL)-Concern Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	677
Least Squares Mean (Standard Error) [Scores on a scale]	26.82 (1.15)	20.27 (1.51)	31.18 (1.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	10.91
	Confidence Interval	(2-Sided) 95% 7.73 to 14.09
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.62
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0010
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.36
	Confidence Interval	(2-Sided) 95% 1.76 to 6.96
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.33
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	6.55
	Confidence Interval	(2-Sided) 95% 3.39 to 9.72
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.61
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

18. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL)-Sleep Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	677
Least Squares Mean (Standard Error) [Scores on a scale]	21.97 (1.10)	18.25 (1.45)	25.71 (1.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	7.46
	Confidence Interval	(2-Sided) 95% 4.40 to 10.51
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.56
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0034
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.74
	Confidence Interval	(2-Sided) 95% 1.24 to 6.23
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.27
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0164
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.72
	Confidence Interval	(2-Sided) 95% 0.68 to 6.76
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.55
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

19. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL)-Social Interaction Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	677
Least Squares Mean (Standard Error) [Scores on a scale]	16.43 (0.89)	12.61 (1.17)	20.11 (0.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	7.50
	Confidence Interval	(2-Sided) 95% 5.03 to 9.97
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.26
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.68
	Confidence Interval	(2-Sided) 95% 1.65 to 5.70
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.03
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0023
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	3.82
	Confidence Interval	(2-Sided) 95% 1.36 to 6.28
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.25
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

20. Secondary Outcome

Title	Change From Baseline in Health Related Quality of Life (HRQL)-Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 12.
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with non-missing change from BL value at Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	701	347	677
Least Squares Mean (Standard Error) [Scores on a scale]	23.70 (1.02)	18.57 (1.33)	27.94 (1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	9.37
	Confidence Interval	(2-Sided) 95% 6.56 to 12.18
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.43
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	4.23
	Confidence Interval	(2-Sided) 95% 1.93 to 6.53
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.17
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was based on an ANCOVA model with terms for treatment, pooled country, centered baseline value and centered baseline by treatment interaction.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0003
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares mean difference
	Estimated Value	5.14
	Confidence Interval	(2-Sided) 95% 2.34 to 7.94
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.43
	Estimation Comments	Note- Standard Error of the Mean in the table refers to Standard Error of the Least Squares Mean.

21. Secondary Outcome

Title	Percentage of Participants Who Became Dry at Week 4.
Description	Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI>0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. The analysis included participants with baseline UUI >0 per 24 hours and non-missing change from baseline to Week 4.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	715	364	704
Number [Percentage of participants]	35.5 4.5%	26.4 6.8%	36.2 4.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0016
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8121
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0015
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

22. Secondary Outcome

Title	Percentage of Participants Who Became Dry at Week 12.
Description	Percentage of participants with no UUI episode for the three day diary, the numerator being the number of participants with no UUI at a visit and the denominator the total number of participants with UUI >0 at baseline. UUI episodes defined as those with USS rating of 5 (unable to hold; leak urine) in the diary.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description
The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 BL or post-BL efficacy assessment. Number of participants with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 12.

Arm/Group Title	Fesoterodine 4 Milligram (mg)	Placebo	Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.	Participants received one tablet of placebo per day for 12 weeks.	Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
Measure Participants	733	370	718
Number [Percentage of participants]	49.2 6.2%	39.5 10.2%	57.8 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fesoterodine 8 mg
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Fesoterodine 8 mg
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0006
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Fesoterodine 4 Milligram (mg), Placebo
	Comments	P-value was obtained from a Cochran-Mantel-Haenszel (CMH) general association test stratified by country.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0027
	Comments	A closed-testing procedure was used for the treatment comparison.
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

	Fesoterodine 4 Milligram (mg)		Placebo		Fesoterodine 8 mg
Time Frame	Baseline to 28 days after the last dose of the study drug
Adverse Event Reporting Description	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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Arm/Group Title	Fesoterodine 4 Milligram (mg)		Placebo		Fesoterodine 8 mg
Arm/Group Description	Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.		Participants received one tablet of placebo per day for 12 weeks.		Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Fesoterodine 4 Milligram (mg)		Placebo		Fesoterodine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/790 (1.3%)		11/386 (2.8%)		10/779 (1.3%)
Cardiac disorders
Atrial fibrillation	0/790 (0%)		1/386 (0.3%)		1/779 (0.1%)
Myocardial infarction	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Eye disorders
Ulcerative keratitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Gastrointestinal disorders
Hemorrhoids	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Pancreatitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Pancreatitis acute	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
General disorders
Chest pain	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Infections and infestations
Appendicitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Herpes simplex ophthalmic	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Infective exacerbation of chronic obstructive airways disease	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Labyrinthitis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Pelvic inflammatory disease	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Pneumonia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Pyelonephritis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Staphylococcal infection	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Viral infection	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Injury, poisoning and procedural complications
Lower limb fracture	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Post procedural hemorrhage	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Wound	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Metabolism and nutrition disorders
Dehydration	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Musculoskeletal and connective tissue disorders
Back pain	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Breast cancer	0/790 (0%)		2/386 (0.5%)		0/779 (0%)
Breast neoplasm	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Colon cancer	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Nervous system disorders
Syncope	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Reproductive system and breast disorders
Endometrial hyperplasia	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Uterine hemorrhage	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Pulmonary embolism	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Vascular disorders
Peripheral artery thrombosis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Peripheral ischemia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Other (Not Including Serious) Adverse Events
	Fesoterodine 4 Milligram (mg)		Placebo		Fesoterodine 8 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	297/790 (37.6%)		103/386 (26.7%)		349/779 (44.8%)
Blood and lymphatic system disorders
Anemia	1/790 (0.1%)		1/386 (0.3%)		2/779 (0.3%)
Lymphadenitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Lymphadenopathy	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Cardiac disorders
Atrial fibrillation	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Bradycardia	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Cardiac failure congestive	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Palpitations	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Sinus tachycardia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Coronary artery disease	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Ear and labyrinth disorders
Eustachian tube obstruction	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Vertigo	3/790 (0.4%)		1/386 (0.3%)		2/779 (0.3%)
Vertigo positional	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Endocrine disorders
Hypothyroidism	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Eye disorders
Blepharitis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Cataract	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Conjunctival irritation	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Dry eye	8/790 (1%)		3/386 (0.8%)		10/779 (1.3%)
Eye allergy	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Eye pain	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Eye swelling	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Glaucoma	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Scintillating scotoma	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Vision blurred	3/790 (0.4%)		0/386 (0%)		4/779 (0.5%)
Visual acuity reduced	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Visual impairment	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Vitreous floaters	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Gastrointestinal disorders
Abdominal discomfort	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Abdominal distension	2/790 (0.3%)		0/386 (0%)		4/779 (0.5%)
Abdominal pain	5/790 (0.6%)		0/386 (0%)		3/779 (0.4%)
Abdominal pain lower	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Abdominal pain upper	1/790 (0.1%)		2/386 (0.5%)		6/779 (0.8%)
Abnormal faeces	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Constipation	12/790 (1.5%)		7/386 (1.8%)		31/779 (4%)
Diarrhoea	13/790 (1.6%)		4/386 (1%)		5/779 (0.6%)
Dry mouth	102/790 (12.9%)		13/386 (3.4%)		203/779 (26.1%)
Dyspepsia	8/790 (1%)		0/386 (0%)		10/779 (1.3%)
Dysphagia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Enteritis	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Flatulence	1/790 (0.1%)		1/386 (0.3%)		3/779 (0.4%)
Frequent bowel movements	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Gastritis	0/790 (0%)		2/386 (0.5%)		0/779 (0%)
Gastrooesophageal reflux disease	5/790 (0.6%)		1/386 (0.3%)		4/779 (0.5%)
Glossodynia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Hemorrhoids	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Hiatus hernia	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Lip dry	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Nausea	11/790 (1.4%)		3/386 (0.8%)		10/779 (1.3%)
Oesophagitis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Palatal oedema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Peptic ulcer hemorrhage	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Stomatitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Tongue disorder	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Toothache	2/790 (0.3%)		1/386 (0.3%)		1/779 (0.1%)
Vomiting	3/790 (0.4%)		0/386 (0%)		3/779 (0.4%)
Tongue dry	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
General disorders
Adverse event	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Asthenia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Chest discomfort	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Chest pain	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Chills	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Face oedema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Fatigue	7/790 (0.9%)		4/386 (1%)		7/779 (0.9%)
Inflammation	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Malaise	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Nodule	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Oedema	0/790 (0%)		1/386 (0.3%)		1/779 (0.1%)
Oedema peripheral	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Pain	2/790 (0.3%)		0/386 (0%)		1/779 (0.1%)
Sluggishness	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Suprapubic pain	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Thirst	0/790 (0%)		1/386 (0.3%)		1/779 (0.1%)
Immune system disorders
Allergic oedema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Food allergy	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Hypersensitivity	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Seasonal allergy	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Infections and infestations
Acute sinusitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Asymptomatic bacteriuria	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Bacteriuria	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Bronchitis	7/790 (0.9%)		4/386 (1%)		5/779 (0.6%)
Cellulitis	2/790 (0.3%)		0/386 (0%)		3/779 (0.4%)
Cervicitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Cystitis	6/790 (0.8%)		0/386 (0%)		6/779 (0.8%)
Diverticulitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Ear infection	1/790 (0.1%)		2/386 (0.5%)		1/779 (0.1%)
External ear cellulitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Eye infection	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Folliculitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Fungal infection	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Gastroenteritis	1/790 (0.1%)		2/386 (0.5%)		2/779 (0.3%)
Gastroenteritis viral	0/790 (0%)		0/386 (0%)		4/779 (0.5%)
Gastrointestinal infection	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Gastrointestinal viral infection	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Gingival infection	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Herpes simplex	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Herpes zoster	1/790 (0.1%)		1/386 (0.3%)		2/779 (0.3%)
Infected bites	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Influenza	2/790 (0.3%)		1/386 (0.3%)		2/779 (0.3%)
Laryngitis	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Lower respiratory tract infection	2/790 (0.3%)		0/386 (0%)		2/779 (0.3%)
Lyme disease	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Mastitis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Nasopharyngitis	24/790 (3%)		18/386 (4.7%)		17/779 (2.2%)
Oral herpes	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Pharyngitis	2/790 (0.3%)		0/386 (0%)		1/779 (0.1%)
Pharyngitis streptococcal	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Pneumonia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Post procedural infection	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Postoperative wound infection	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Rash pustular	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Respiratory tract infection	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Respiratory tract infection viral	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Rhinitis	0/790 (0%)		3/386 (0.8%)		0/779 (0%)
Sinusitis	6/790 (0.8%)		3/386 (0.8%)		5/779 (0.6%)
Subcutaneous abscess	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Tinea cruris	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Tooth abscess	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Tooth infection	2/790 (0.3%)		0/386 (0%)		5/779 (0.6%)
Upper respiratory tract infection	7/790 (0.9%)		3/386 (0.8%)		5/779 (0.6%)
Urinary tract infection	16/790 (2%)		5/386 (1.3%)		17/779 (2.2%)
Vaginal infection	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Vulvovaginal mycotic infection	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Injury, poisoning and procedural complications
Arthropod bite	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Arthropod sting	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Burns second degree	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Concussion	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Contusion	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Epicondylitis	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Fall	2/790 (0.3%)		0/386 (0%)		2/779 (0.3%)
Foot fracture	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Laceration	0/790 (0%)		1/386 (0.3%)		1/779 (0.1%)
Ligament sprain	3/790 (0.4%)		0/386 (0%)		0/779 (0%)
Limb crushing injury	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Lower limb fracture	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Muscle injury	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Muscle strain	1/790 (0.1%)		1/386 (0.3%)		0/779 (0%)
Procedural pain	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Thermal burn	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Tooth fracture	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Wound	0/790 (0%)		1/386 (0.3%)		1/779 (0.1%)
Wrist fracture	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Investigations
Bacterial test positive	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Biopsy breast	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Blood glucose increased	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Blood pressure increased	2/790 (0.3%)		0/386 (0%)		2/779 (0.3%)
Body temperature increased	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Glucose urine present	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Red blood cells urine positive	1/790 (0.1%)		1/386 (0.3%)		1/779 (0.1%)
Smear buccal	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Smear cervix abnormal	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Weight increased	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
White blood cells urine positive	1/790 (0.1%)		1/386 (0.3%)		0/779 (0%)
Metabolism and nutrition disorders
Decreased appetite	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Dehydration	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Diabetes mellitus	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Fluid retention	0/790 (0%)		1/386 (0.3%)		2/779 (0.3%)
Glucose tolerance impaired	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Gout	1/790 (0.1%)		1/386 (0.3%)		0/779 (0%)
Hypercholesterolaemia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Hyperlipidaemia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Type 2 diabetes mellitus	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Vitamin B complex deficiency	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Vitamin B12 deficiency	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/790 (0.6%)		1/386 (0.3%)		3/779 (0.4%)
Arthritis	1/790 (0.1%)		1/386 (0.3%)		1/779 (0.1%)
Back pain	9/790 (1.1%)		0/386 (0%)		8/779 (1%)
Bone pain	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Bursitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Fibromyalgia	1/790 (0.1%)		1/386 (0.3%)		0/779 (0%)
Intervertebral disc degeneration	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Intervertebral disc protrusion	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Joint swelling	2/790 (0.3%)		1/386 (0.3%)		0/779 (0%)
Muscle disorder	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Muscle spasms	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Muscle twitching	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Musculoskeletal chest pain	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Musculoskeletal pain	1/790 (0.1%)		2/386 (0.5%)		0/779 (0%)
Musculoskeletal stiffness	2/790 (0.3%)		0/386 (0%)		1/779 (0.1%)
Myalgia	1/790 (0.1%)		1/386 (0.3%)		0/779 (0%)
Neck pain	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Osteoarthritis	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Pain in extremity	2/790 (0.3%)		2/386 (0.5%)		1/779 (0.1%)
Periarthritis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Plantar fasciitis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Synovial cyst	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Tendonitis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Malignant melanoma in situ	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Seborrhoeic keratosis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Nervous system disorders
Ageusia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Amnesia	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Anosmia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Burning sensation	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Dizziness	10/790 (1.3%)		1/386 (0.3%)		2/779 (0.3%)
Dysgeusia	5/790 (0.6%)		0/386 (0%)		1/779 (0.1%)
Head discomfort	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Headache	8/790 (1%)		2/386 (0.5%)		12/779 (1.5%)
Hypoaesthesia	2/790 (0.3%)		1/386 (0.3%)		0/779 (0%)
Migraine	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Neuritis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Paraesthesia	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Parosmia	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Poor quality sleep	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Presyncope	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Radiculitis lumbosacral	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Radiculopathy	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Sciatica	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Sinus headache	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Somnolence	2/790 (0.3%)		1/386 (0.3%)		1/779 (0.1%)
Vascular encephalopathy	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Psychiatric disorders
Abnormal dreams	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Aggression	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Anxiety	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Depression	2/790 (0.3%)		0/386 (0%)		1/779 (0.1%)
Depressive symptom	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Insomnia	0/790 (0%)		2/386 (0.5%)		1/779 (0.1%)
Libido decreased	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Loss of libido	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Mood swings	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Performance fear	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Premature ejaculation	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Sleep disorder	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Stress	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Tic	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Renal and urinary disorders
Bladder pain	0/790 (0%)		2/386 (0.5%)		1/779 (0.1%)
Bladder prolapse	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Dysuria	1/790 (0.1%)		3/386 (0.8%)		5/779 (0.6%)
Enuresis	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Glycosuria	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Haematinuria	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Haematuria	1/790 (0.1%)		0/386 (0%)		3/779 (0.4%)
Incontinence	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Micturition urgency	0/790 (0%)		2/386 (0.5%)		1/779 (0.1%)
Nephrolithiasis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Nocturia	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Pollakiuria	0/790 (0%)		2/386 (0.5%)		0/779 (0%)
Renal colic	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Renal cyst	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Terminal dribbling	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Urethral pain	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Urge incontinence	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Urinary hesitation	1/790 (0.1%)		0/386 (0%)		2/779 (0.3%)
Urinary incontinence	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Urinary retention	2/790 (0.3%)		0/386 (0%)		2/779 (0.3%)
Urine flow decreased	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Urine odour abnormal	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Reproductive system and breast disorders
Breast cyst	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Breast mass	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Breast tenderness	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Pelvic pain	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Premenstrual syndrome	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Uterine spasm	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Vaginal discharge	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Respiratory, thoracic and mediastinal disorders
Aspiration	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Asthma	1/790 (0.1%)		1/386 (0.3%)		1/779 (0.1%)
Cough	6/790 (0.8%)		1/386 (0.3%)		7/779 (0.9%)
Dry throat	3/790 (0.4%)		0/386 (0%)		4/779 (0.5%)
Dysphonia	0/790 (0%)		0/386 (0%)		2/779 (0.3%)
Dyspnoea	2/790 (0.3%)		1/386 (0.3%)		0/779 (0%)
Nasal congestion	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Nasal dryness	1/790 (0.1%)		0/386 (0%)		4/779 (0.5%)
Oropharyngeal pain	2/790 (0.3%)		1/386 (0.3%)		3/779 (0.4%)
Pharyngeal oedema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Pleurisy	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Respiratory tract congestion	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Sinus congestion	1/790 (0.1%)		2/386 (0.5%)		1/779 (0.1%)
Sneezing	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Throat irritation	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Throat tightness	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Upper respiratory tract congestion	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Wheezing	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Skin and subcutaneous tissue disorders
Dermal cyst	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Dermatitis	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Dermatitis allergic	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Dermatitis contact	0/790 (0%)		0/386 (0%)		4/779 (0.5%)
Dry skin	2/790 (0.3%)		2/386 (0.5%)		2/779 (0.3%)
Eczema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Erythema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Generalised erythema	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Granuloma annulare	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Hyperhidrosis	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Intertrigo	0/790 (0%)		0/386 (0%)		1/779 (0.1%)
Night sweats	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Pruritus	4/790 (0.5%)		0/386 (0%)		3/779 (0.4%)
Rash	1/790 (0.1%)		2/386 (0.5%)		3/779 (0.4%)
Skin lesion	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Skin ulcer	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Telangiectasia	2/790 (0.3%)		0/386 (0%)		0/779 (0%)
Urticaria	1/790 (0.1%)		0/386 (0%)		1/779 (0.1%)
Surgical and medical procedures
Aneurysm repair	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Cataract operation	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Haemorrhoid operation	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Mass excision	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Mole excision	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Skin lesion excision	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Tendon operation	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Tooth extraction	0/790 (0%)		1/386 (0.3%)		0/779 (0%)
Vascular disorders
Hot flush	1/790 (0.1%)		0/386 (0%)		0/779 (0%)
Hypertension	6/790 (0.8%)		3/386 (0.8%)		4/779 (0.5%)
Hypotension	0/790 (0%)		1/386 (0.3%)		0/779 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01302067

Other Study ID Numbers:

A0221095
EIGHT

First Posted:

Feb 23, 2011

Last Update Posted:

Mar 26, 2014

Last Verified:

Feb 1, 2014