Fesoterodine Flexible Dose Study | NCT00536484

Fesoterodine Flexible Dose Study | NCT00536484 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Fesoterodine (Double-Blind)	Experimental		Drug: Fesoterodine
Placebo (Double-Blind)	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fesoterodine	Drug	4mg tablets once daily for 2 weeks, then either 4mg or 8mg tablets once daily for 10 weeks. Subjects were instructed to take 1 tablet every evening within 4 hours prior to bedtime with water, swallowed whole without chewing.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.	The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at Week 12 minus mean at Baseline	Baseline and Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline	The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit. Change: mean at observation minus mean at baseline	Baseline, Week 2 and Week 6

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Mobile	Alabama	36608	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37160401	Derived	Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG00021 subjects FG00134 subjects
Withdrawal by Subject		FG00011 subjects FG00111 subjects
Lost to Follow-up		FG0008 subjects FG0016 subjects
Lack of Efficacy		FG00016 subjects FG0015 subjects
Other		FG0004 subjects FG0010 subjects

Arm/Group Information

ID	Title	Description
BG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
BG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.1± 12.9 BG00159.7± 13.7 BG00259.9± 13.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000368 BG001364 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Mean Number of Micturition Episodes Per 24 Hours at Week 12 Relative to Baseline.

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at Week 12 minus mean at Baseline

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12 (last observation carried forward [LOCF)). The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline.](streamdown:incomplete-link)

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Units	Counts
Participants	OG000434 OG001428

Title

Denominators

Categories

Title	Measurements
	OG000-2.1± 0.1 OG001-2.9± 0.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Null hypothesis: the mean change from baseline in micturitions per 24 hours in the fesoterodine group is the same as in the placebo group at Week 12. A sample size of 350 in each arm had at least 85% power to detect a difference of 0.8 between flexible dose fesoterodine & placebo assuming a standard deviation of 3.52 using a 2-sample t-test with a 0.05 2-sided significance level. Accounting for 10% of randomized subjects not having the primary endpoint data, 390 subjects were needed in each arm	ANCOVA	Terms for treatment, center and baseline as covariate and baseline by treatment interaction.	0.0002	Significance level p <0.05	Mean Difference (Final Values)	-0.7	Standard Error of the Mean	0.2		95	-1.1	-0.4

Secondary

Change in Mean Number of Micturition Episodes Per 24 Hours Relative to Baseline

The number of micturitions per 24 hours was calculated as the sum of all micturitions divided by the total number of diary days collected at that visit.

Change: mean at observation minus mean at baseline

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2 or Week 6 (last observation carried forward [LOCF]).

The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline (n=placebo; n=fesoterodine)

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2 and Week 6

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Number of Urgency Episodes Per 24 Hours Relative to Baseline

Change in number of urgency episodes (urinary sensation scale [USS] rating of 3 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. The number of urgency episodes per 24 hours was calculated as the sum of all urgency episodes divided by the total number of diary days collected at that visit.

Number of subjects with Baseline Urgency Episodes >0 per 24 hours and non missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Number of Severe Urgency Episodes Per 24 Hours Relative to Baseline

Change in number of severe urgency episodes (urinary sensation scale [USS] rating of 4 or more) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine. Number of severe urgency episodes per 24 hours calculated as sum of all severe urgency episodes divided by total number of diary days collected at that visit.

Number of subjects with baseline severe urgency episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only those with at least 1 episode during baseline 3-day diary period were included.

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Relative to Baseline

Change in number of UUI episodes (urinary sensation scale [USS] rating of 5) recorded in the bladder diary. Scale: 0=no feeling of urgency to 5=unable to hold; leak urine

Number of subjects with Baseline UUI >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Nocturnal Micturition Episodes Per 24 Hours Relative to Baseline

Change in number of nocturnal micturitions (NM) recorded in the bladder diary. NM were defined as micturitions that occurred between the time the subject went to bed and the time he or she arose to start the next day. The number of NM per 24 hours was calculated as the sum of all NM divided by the total number of diary days collected at that visit.

Number of subjects with Baseline Nocturnal Micturitions >0 per 24 and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Number of Nocturnal Urgency Episodes Per 24 Hours Relative to Baseline

Change in number of nocturnal urgency episodes (NUE) recorded in bladder diary. NUE had urinary sensation scale (USS) rating of 3 or more that occurred between time subject went to bed and time he or she arose to start next day. Number of NUE per 24 hours was calculated as sum of all NUE divided by total number of diary days collected at that visit

Number of subjects with Nocturnal Urgency Episodes >0 per 24 hours and non-missing change from baseline to Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF). Only subjects with at least 1 episode during baseline 3-day diary period were included in analysis.

Posted

Least Squares Mean

Standard Error

number of episodes per 24 hours

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Frequency-urgency Sum Per 24 Hours Relative to Baseline

Change in frequency urgency sum is total urinary sensation scale (USS) ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold:leak urine. Numerical decrease indicates improvement

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).

Number analyzed=participants at Week 12 LOCF.

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Symptom Bother Scale

Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a negative change indicates improvement.

Change: mean at Week 12 minus mean at baseline

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.

The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Overactive Bladder Questionnaire (OAB-q) at Week 12 Relative to Baseline - Health Related Quality of Life (HRQL) Subscales

Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed a positive change indicates improvement.

Change: mean at Week 12 minus mean at baseline.

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 12.

The FAS included all participants who took at least 1 dose of assigned study drug and had at least 1 valid efficacy assessment, either at baseline or post baseline

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Categorical Change in Patient Perception of Bladder Condition (PPBC) Score Relative to Baseline

PPBC scale range: 1='does not cause me any problems at all' to 6='causes me many severe problems'. Major improvement=negative score change of 2 or more from baseline; minor improvement=negative score change of 1 or more from baseline; no change=0 score change from baseline; Deterioration=positive score change from baseline

Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.

Number analyzed=participants at Week 12 LOCF.

Posted

Number

percentage of participants

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Categorical Change in Urgency Perception Scale (UPS) Relative to Baseline

UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet [without leaking]"). Improvement: positive score change; No change: score change=0; Deterioration: negative score change

Participants in the Full Analysis Set (FAS) with non-missing baseline values and Week 2, Week 6 (last observation carried forward [LOCF]) or Week 12 (LOCF) values.

Number analyzed=participants at Week 12 LOCF.

Posted

Number

percentage of participants

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Secondary

Change in Urgency Severity Visual Analog Scale (VAS) Relative to Baseline

The urgency severity VAS Scale records the subject's assessment of the severity of urgency. VAS scale ranges from 1 'Very Mild' to 10 'Very Severe'. Negative change indicated improvement.

Change: mean at observation minus mean at baseline.

Participants in the Full Analysis Set (FAS) with non-missing numerical change from baseline to Week 2, Week 6 or Week 12 (last observation carried forward [LOCF]).

Number analyzed=participants at Week 12 LOCF

Posted

Least Squares Mean

Standard Error

scores on a scale

Baseline, Week 2, Week 6 and Week 12

ID	Title	Description
OG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
OG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.			7		130
EG001	Fesoterodine	All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.			5		199

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Intestinal obstruction	Gastrointestinal disorders	MedDRA (v11.1)	Systematic Assessment	EG0000 affected445 at risk EG0011 affected438 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Vomiting	Gastrointestinal disorders		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Chest pain	General disorders		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Cellulitis	Infections and infestations		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Pneumonia	Infections and infestations		Systematic Assessment	EG0002 affected445 at risk EG0012 affected438 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG0002 affected445 at risk EG0010 affected438 at risk
Fall	Injury, poisoning and procedural complications		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Arthralgia	Musculoskeletal and connective tissue disorders		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)		Systematic Assessment	EG0000 affected445 at risk EG0011 affected438 at risk
Asthma	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0000 affected445 at risk EG0011 affected438 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Deep vein thrombosis	Vascular disorders		Systematic Assessment	EG0000 affected445 at risk EG0011 affected438 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Hypotension	Vascular disorders	MedDRA 11.1	Systematic Assessment	EG0001 affected445 at risk EG0010 affected438 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 11.1	Systematic Assessment	EG0000 affected445 at risk EG0011 affected438 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dry eye	Eye disorders	MedDRA (v11.1)	Systematic Assessment	EG0008 affected445 at risk EG00113 affected438 at risk
Constipation	Gastrointestinal disorders		Systematic Assessment	EG00025 affected445 at risk EG00148 affected438 at risk
Diarrhoea	Gastrointestinal disorders		Systematic Assessment	EG00019 affected445 at risk EG0019 affected438 at risk
Dry mouth	Gastrointestinal disorders		Systematic Assessment	EG00034 affected445 at risk EG001113 affected438 at risk
Nausea	Gastrointestinal disorders		Systematic Assessment	EG00018 affected445 at risk EG0016 affected438 at risk
Fatigue	General disorders		Systematic Assessment	EG0002 affected445 at risk EG00111 affected438 at risk
Nasopharyngitis	Infections and infestations		Systematic Assessment	EG00025 affected445 at risk EG00119 affected438 at risk
Upper respiratory tract infection	Infections and infestations		Systematic Assessment	EG00023 affected445 at risk EG00121 affected438 at risk
Urinary tract infection	Infections and infestations		Systematic Assessment	EG00012 affected445 at risk EG0018 affected438 at risk
Headache	Nervous system disorders		Systematic Assessment	EG00015 affected445 at risk EG00119 affected438 at risk
Insomnia	Psychiatric disorders		Systematic Assessment	EG0002 affected445 at risk EG00111 affected438 at risk
Cough	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0002 affected445 at risk EG0019 affected438 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	EG0001 affected445 at risk EG0019 affected438 at risk

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D059411	Lower Urinary Tract Symptoms
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment, baseline covariate and baseline by treatment interaction	0.0136	Significance level p <0.05	Mean Difference (Final Values)	-0.4	Standard Error of the Mean	0.2		95	-0.8	-0.1			Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	0.0002	Significance level p <0.05	Mean Difference (Final Values)	-0.7	Standard Error of the Mean	0.2		95	-1.1	-0.3			Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=431; n=427)

Title	Measurements
	OG000-1.9± 0.2 OG001-2.3± 0.2

Week 6 (n=434; n=428)

Title	Measurements
	OG000-2.9± 0.2 OG001-3.5± 0.2

Week 12 (n=434; n=428)

Title	Measurements
	OG000-3.0± 0.2 OG001-4.0± 0.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.1057	Significance level p <0.05	Mean Difference (Final Values)	-0.4	Standard Error of the Mean	0.2	95	-0.9	0.1	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0338	Significance level p <0.05	Mean Difference (Final Values)	-0.6	Standard Error of the Mean	0.3	95	-1.1	-0.0	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0003	Significance level p <0.05	Mean Difference (Final Values)	-1.0	Standard Error of the Mean	0.3	95	-1.5	-0.5	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=393; n=403)

Title	Measurements
	OG000-1.6± 0.1 OG001-1.8± 0.1

Week 6 (n=396; n=404)

Title	Measurements
	OG000-2.2± 0.1 OG001-2.6± 0.1

Week 12 (n=396; n=404)

Title	Measurements
	OG000-2.2± 0.1 OG001-2.9± 0.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.1666	Significance level p <0.05	Mean Difference (Final Values)	-0.3	Standard Error of the Mean	0.2	95	-0.6	0.1	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0506	Significance level p <0.05	Mean Difference (Final Values)	-0.4	Standard Error of the Mean	0.2	95	-0.8	0.0	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0014	Significance level p <0.05	Mean Difference (Final Values)	-0.6	Standard Error of the Mean	0.2	95	-1.0	-0.2	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=255; n=251)

Title	Measurements
	OG000-0.9± 0.1 OG001-1.1± 0.1

Week 6 (n=257; n=251)

Title	Measurements
	OG000-1.2± 0.1 OG001-1.5± 0.1

week 12 (n=257; n=251)

Title	Measurements
	OG000-1.2± 0.1 OG001-1.5± 0.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	0.2054	Significance level p <0.05	Mean Difference (Final Values)	-0.2	Standard Error of the Mean	0.1	95	-0.4	0.1	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	0.0225	Significance level p <0.05	Mean Difference (Final Values)	-0.3	Standard Error of the Mean	0.1	95	-0.6	-0.0	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	0.0167	Significance level p <0.05	Mean Difference (Final Values)	-0.3	Standard Error of the Mean	0.1	95	-0.6	-0.1	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=420; n=417)

Title	Measurements
	OG000-0.5± 0.1 OG001-0.5± 0.1

Week 6 (n=423; n=418)

Title	Measurements
	OG000-0.7± 0.1 OG001-0.7± 0.1

Week 12 (n=423; n=418)

Title	Measurements
	OG000-0.7± 0.1 OG001-0.8± 0.1

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANOVA	0.8019	Significance level p <0.05	Mean Difference (Final Values)	-0.0	Standard Error of the Mean	0.1	95	-0.2	0.1	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANOVA	0.3881	Significance level p <0.05	Mean Difference (Final Values)	-0.1	Standard Error of the Mean	0.1	95	-0.2	0.1	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANOVA	0.3240	Significance level p <0.05	Mean Difference (Final Values)	-0.1	Standard Error of the Mean	0.1	95	-0.2	0.1	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=411; n=408)

Title	Measurements
	OG000-0.6± 0.1 OG001-0.6± 0.1

Week 6 (n=414; n=409)

Title	Measurements
	OG000-0.8± 0.1 OG001-0.9± 0.1

Week 12 (n=414; n=409)

Title	Measurements
	OG000-0.9± 0.1 OG001-1.0± 0.1

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANOVA	0.8279	Significance level p <0.05	Mean Difference (Final Values)	-0.0	Standard Error of the Mean	0.1	95	-0.2	0.1	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANOVA	0.5059	Significance level p <0.05	Mean Difference (Final Values)	-0.1	Standard Error of the Mean	0.1	95	-0.2	0.1	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANOVA	0.0806	Significance level p <0.05	Mean Difference (Final Values)	-0.2	Standard Error of the Mean	0.1	95	-0.4	0.0	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=431; n=427)

Title	Measurements
	OG000-6.5± 0.5 OG001-8.3± 0.5

Week 6 (n=434; n=428)

Title	Measurements
	OG000-9.8± 0.6 OG001-12.5± 0.6

Week 12 (n=434; n=428)

Title	Measurements
	OG000-10.3± 0.6 OG001-13.6± 0.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0203	Significance level p <0.05	Mean Difference (Final Values)	-1.7	Standard Error of the Mean	0.7	95	-3.2	-0.3	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	0.0007	Significance level p <0.05	Mean Difference (Final Values)	-2.7	Standard Error of the Mean	0.8	95	-4.2	-1.1	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	-3.3	Standard Error of the Mean	0.8	95	-4.9	-1.7	No	Superiority or Other

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	-7.8	Standard Error of the Mean	1.5		95	-10.7	-4.9			Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other

Title

Denominators

Categories

HRQL concern domain (n=383; n=372)

Title	Measurements
	OG00020.9± 1.1 OG00129.3± 1.2

HRQL coping domain (n=383; n=372)

Title	Measurements
	OG00020.2± 1.2 OG00127.2± 1.2

HRQL sleep domain (n=383; n=372)

Title	Measurements
	OG00021.2± 1.2 OG00125.9± 1.2

HRQL social interaction domain (n=380; n=372)

Title	Measurements
	OG00011.6± 0.8 OG00115.3± 0.8

HRQL scale score total (n=380; n=372)

Title	Measurements
	OG00018.9± 1.0 OG00125.1± 1.0

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 12 minus Baseline Concern domain	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	8.4	Standard Error of the Mean	1.6	95	5.3	11.5	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline Coping domain	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	7.1	Standard Error of the Mean	1.6	95	3.9	10.2	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline Sleep domain	ANCOVA	Terms for center, treatment and baseline as covariate	0.0036	Significance level p <0.05	Mean Difference (Final Values)	4.7	Standard Error of the Mean	1.6	95	1.5	7.8		No	Superiority or Other
OG000 OG001	Week 12 minus Baseline Social interaction domain	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	0.0007	Significance level p <0.05	Mean Difference (Final Values)	3.7	Standard Error of the Mean	1.1	95	1.6	5.8	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline HRQL scale score total	ANCOVA	Terms for center, treatment and baseline as covariate and baseline by treatment interaction	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	6.2	Standard Error of the Mean	1.3	95	3.6	8.9	Since centered baseline was used in the model, the LS mean difference and its 95% CI were calculated at mean baseline	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=440; n=434): major improvement

Title	Measurements
	OG00013.2 OG00116.6

Week 2: minor improvement

Title	Measurements
	OG00034.8 OG00139.4

Week 2: no change

Title	Measurements
	OG00045.2 OG00139.4

Week 2: deterioration

Title	Measurements
	OG0006.8 OG0014.6

Week 6 (n=442; n=435): major improvement

Title	Measurements
	OG00024.7 OG00132.4

Week 6: minor improvement

Title	Measurements
	OG00034.8 OG00135.9

Week 6: no change

Title	Measurements
	OG00033.5 OG00127.8

Week 6: deterioration

Title	Measurements
	OG0007.0 OG0013.9

Week 12 (n=442; n=435): major improvement

Title	Measurements
	OG00029.2 OG00136.8

Week 12: minor improvement

Title	Measurements
	OG00031.0 OG00134.5

Week 12: no change

Title	Measurements
	OG00033.0 OG00125.5

Week 12: deterioration

Title	Measurements
	OG0006.8 OG0013.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Treatment difference at Week 2	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0087	Significance level p <0.05	95	No	Superiority or Other
OG000 OG001	Treatment difference at Week 6	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0008	Significance level p <0.05	95	No	Superiority or Other
OG000 OG001	Treatment difference at Week 12	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0006	Significance level p <0.05	95	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=441; n=434): improvement

Title	Measurements
	OG00022.9 OG00129.3

Week 2: no change

Title	Measurements
	OG00069.2 OG00164.5

Week 2: deterioration

Title	Measurements
	OG0007.9 OG0016.2

Week 6 (n=443; n=435): improvement

Title	Measurements
	OG00030.2 OG00137.5

Week 6: no change

Title	Measurements
	OG00065.0 OG00158.6

Week 6: deterioration

Title	Measurements
	OG0004.7 OG0013.9

Week 12 (n=443; n=435): improvement

Title	Measurements
	OG00030.9 OG00141.8

Week 12: no change

Title	Measurements
	OG00062.3 OG00152.4

Week 12: deterioration

Title	Measurements
	OG0006.8 OG0015.7

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Treatment difference at Week 2	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0129	Significance level p <0.05	95	No	Superiority or Other
OG000 OG001	Treatment difference at Week 6	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0100	Significance level p <0.05	95	No	Superiority or Other
OG000 OG001	Treatment difference at Week 12	Cochran-Mantel-Haenszel	The CMH test used modified ridit scores which were based on the ranks of the observations rather than the observed values.	0.0009	Significance level p <0.05	95	No	Superiority or Other

Title

Denominators

Categories

Week 2 (n=441; n=432)

Title	Measurements
	OG000-0.8± 0.1 OG001-1.4± 0.1

Week 6 (n=443; n=434)

Title	Measurements
	OG000-1.4± 0.1 OG001-2.2± 0.1

Week 12 (n=443; n=434)

Title	Measurements
	OG000-1.4± 0.1 OG001-2.4± 0.1

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type
OG000 OG001	Week 2 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	-0.6	Standard Error of the Mean	0.1	95	-0.9	-0.4	No	Superiority or Other
OG000 OG001	Week 6 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	-0.8	Standard Error of the Mean	0.1	95	-1.1	-0.5	No	Superiority or Other
OG000 OG001	Week 12 minus Baseline	ANCOVA	Terms for center, treatment and baseline covariate	<0.0001	Significance level p <0.05	Mean Difference (Final Values)	-1.0	Standard Error of the Mean	0.2	95	-1.3	-0.7	No	Superiority or Other