Prostatic Hyperplasia
Conditions
Brief summary
Study FDC114615 is a two year, multi-centre, randomised, open-label trial to assess the efficacy of Dutasteride plus tamsulosin when compared to the standard practice of watchful waiting, with a defined escalation to tamsulosin in treatment naive men with symptomatic benign prostate hyperplasia (BPH). Once consented, each subject will undergo screening procedures to ensure the prostate volume and post void residual are within eligible range. If all entry criteria are met, subjects will be randomised (1:1) to receive Dutasteride plus tamsulosin with lifestyle advice or watchful waiting, with lifestyle advice, with a defined escalation to tamsulosin. Escalation will be initiated when no improvement from baseline is scored using the International Prostate Symptom Score (version 2) (IPSS) questionnaire. After randomisation, the subjects return to site at one month, then every 13 weeks until two years of treatment is complete or they are withdrawn. Key assessments, such as Adverse Events (AE's) and concomitant medication monitoring and completion of the quality of life questionnaires are performed at each visit and the data recorded.
Detailed description
This will be a European, multicentre, randomised, open-label, parallel group study. The aim of the study is to investigate whether Dutasteride plus Tamulson treatment with lifestyle advice is more effective than watchful waiting treatment plus lifestyle advice plus step-up therapy with tamsulosin for improvement of symptoms and Acte Urinary Retention (AUR) and BPH-related prostatic surgery, in older men (≥50 yrs), with moderate symptoms of BPH (IPSS 8-19), enlarged prostates (≥30cc) and Prostate Specific Antigen (PSA) ≥1.5ng/mL. Data from all participating centres will be pooled prior to analysis. Investigative centres will be pooled a priori into clusters based on geographic location; these clusters may be used in analyses to adjust for site effects. Clusters will be defined once all investigative centres have been identified and randomisation has been completed. Subjects will be screened for inclusion into the study and eligible subjects will be randomised by investigative centre. Subjects will be allocated to one of two treatment groups, according to a pre-determined randomisation schedule (in a 1:1 ratio): * Dutasteride plus tamsulosin once daily plus lifestyle advice. * Watchful waiting plus lifestyle advice. Escalation to tamsulosin 0.4 mg once daily at any visit from Week 4 if any IPSS measurement shows no improvement or worsening from baseline. At any study visit, if the IPSS is the same or greater than the baseline value for that subject, tamsulosin 0.4 mg once daily will be initiated. If tamsulosin is initiated, it will be continued for the remainder of the study unless the subject elects to withdraw from the study. Initiation of tamsulosin will be recorded in the electronic case report form (eCRF.) Subjects will self-administer study medication once daily for up to 104 weeks, (up to 100 weeks for those on tamsulosin). Subjects will return to the clinic at 4 weeks post-randomisation and then at 13-week intervals post-randomisation during the 2-year treatment period (i.e. at 4, 13, 26, 39, 52, 65, 78, 91 and 104 weeks) for the assessments listed as in Appendix 1 Time and Events Schedule. Approximately 760, treatment naive men with symptomatic BPH will be randomised into the study in order to achieve at least 592 evaluable subjects. 380 into the Dutasteride plus tamsulosin with lifestyle advice arm and 380 into the watchful waiting plus lifestyle advice arm. Treatment naïve is defined as a man that has recently been diagnoses with BPH whom has received no prescribed therapeutic treatment. For example, medicines such as 5 α-reductase inhibitors (5-ARIs) or invasive procedures such as transurethral resection of the prostate (TURP) prescribed to directly treat the BPH symptoms are considered therapeutic treatments. As per the entry criteria, phytotherapy is allowed unless it was performed less than two weeks prior to the screening visit. The anticipated recruitment period will be approximately 6 months. The study will be conducted in approximately 8 countries within Europe.
Interventions
Take 1 capsule daily
DRUGtamsulosin
Take 1 capsule daily when escalation criteria met
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged ≥50 years. * A confirmed clinical diagnosis of BPH. * International Prostate Symptom Score (IPSS) 8-19 at Visit 1 (screening). * Prostate volume ≥30 cc (by transrectal ultrasonography; TRUS). * Total serum prostate specific antigen (PSA) ≥1.5 ng/mL at Visit 1 (screening). * Willing and able to give signed written informed consent and comply with study procedures. * Fluent and literate in local language with the ability to read, comprehend and record information on the IPSS and BII questionnaires. * Able to swallow and retain oral medication. * Willing and able to participate in the study for the full 2 years. * Men with a female partner of childbearing potential must either agree to use effective contraception or have had a prior vasectomy. Contraception must be used from 2 weeks prior to administration of the first dose of study treatment until at least 5 half-lives for the drug plus 3 months to allow clearance of any altered sperm after the last dose of study treatment. * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Note: If total serum PSA is \>4 ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further Digital rectal examination (DRE), review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice
Exclusion criteria
* Subjects meeting any of the following criteria must not be enrolled in the study: * Total serum PSA \>10.0 ng/mL at Visit 1 (screening). * History or evidence of prostate cancer (e.g. positive biopsy or ultrasound within the previous 6 months, suspicious DRE and/or rising PSA). Excluded medication and therapies Current or any prior use of the following prohibited medications * a 5α-reductase inhibitor (finasteride or dutasteride), * anti-cholinergics (e.g. oxybutynin, propantheline) * an alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) for BPH or Lower urinary tract symptoms (LUTS) * any drugs with anti-androgenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents) within the previous 6 months. * any drugs noted for gynaecomastia effects, or could affect prostate volume, within 6 months of the Visit 1 * any investigational or marketed study drug within 30 days or 5 half-lives, (whichever is longer), preceding the first dose of study treatment. Current use of: * any alpha-adrenoreceptor blocker (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) * anabolic steroids. * drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin. * Use of phytotherapy for BPH within 2 weeks prior to Visit 1 (screening) and/or predicted to need phytotherapy during the study. Have a known (immediate or delayed) hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study medication or excipients that, in the opinion of the Investigator or GlaxoSmithKline contraindicates their participation. Recent Medical Procedures * Previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive or minimally invasive procedures to treat BPH. * History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to Visit 1 (screening). Catheterisation (\<10F) is acceptable with no time restriction. Medical history * History of AUR within 3 months prior to Visit 1 (screening). * Post-void residual volume \>250 mL (suprapubic ultrasound) at Visit 1 (screening).. * Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). * History of 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy for hypertension. * History of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. * History of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy. * History of hepatic impairment or abnormal liver function tests at Visit 1 (screening). (defined as Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) or alkaline phosphatase \>2 times the Upper limit of normal (ULN) , or total bilirubin \>1.5 times the ULN, (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome). * History of renal insufficiency, or serum creatinine \>1.5 times the upper limit of normal at Visit 1 (screening).. * Prior history of malignancies (other than basal cell carcinoma or squamous cell carcinoma of the skin) within the past 5 years. Subjects who have had no evidence of the malignancy for ≥5 years are eligible. * History of any illness (including psychiatric) that in the opinion of the investigator might confound the results of the study or poses additional risk to the subject. * Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. * History or current evidence of drug or alcohol abuse within the previous 12 months. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator or GSK Medical Monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | Each participant was asked the following question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. This response was rated from 0 (delighted) to 6 (terrible). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Events of Clinical Progression (CP) of BPH | Up to 2 years | The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS \>=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing. |
| Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Up to Month 24 | CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS \>=3 points from Baseline \[Visit 2\]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group. |
| Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: \>=1 point through \>=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: \>0 percent, \>=10 percent, \>=20 percent, \>=25 percent, \>=30 percent, \>=40 percent, and \>=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: \>=2 points, \>=3 points, and percent change \>=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). |
| Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. |
| Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 | The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. |
| Exposure to Study Drug | Up to 2 years | Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group. |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Up to 2 years | A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of \>=5%) and SAEs. |
| Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Up to Month 24 | BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate \[TURP\], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries. |
Countries
France, Germany, Greece, Italy, Netherlands, Romania, Spain, United Kingdom
Participant flow
Pre-assignment details
Treatment-naïve men with symptomatic benign prostatic hyperplasia (BPH) meeting eligibility criteria were enrolled and were randomized in a 1:1 ratio to receive dutasteride plus tamsulosin once daily plus lifestyle advice or watchful waiting plus lifestyle advice.
Participants by arm
| Arm | Count |
|---|---|
| Dutasteride Plus Tamsulosin Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months. | 369 |
| Watchful Waiting All: Escalated Yes and No All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No). | 373 |
| Total | 742 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 28 | 13 |
| Overall Study | Lack of Efficacy | 7 | 5 |
| Overall Study | Lost to Follow-up | 7 | 9 |
| Overall Study | Physician Decision | 6 | 11 |
| Overall Study | Protocol Violation | 1 | 7 |
| Overall Study | Withdrawal by Subject | 28 | 28 |
Baseline characteristics
| Characteristic | Watchful Waiting All: Escalated Yes and No | Total | Dutasteride Plus Tamsulosin |
|---|---|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 7.34 | 66.2 Years STANDARD_DEVIATION 7.56 | 66.3 Years STANDARD_DEVIATION 7.78 |
| Race/Ethnicity, Customized African American/African Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Missing | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized Mixed Race | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 363 Participants | 720 Participants | 357 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 373 Participants | 742 Participants | 369 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 43 / 369 | 13 / 373 | 12 / 229 |
| serious Total, serious adverse events | 38 / 369 | 25 / 373 | 19 / 229 |
Outcome results
Primary
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach
The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates delighted and 6 indicates terrible. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 9, n=359, 368 | -5.1 Scores on a scale | Standard Error 0.22 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 18, n=359, 368 | -5.1 Scores on a scale | Standard Error 0.25 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 1, n=358, 367 | -3.2 Scores on a scale | Standard Error 0.21 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 3, n=359, 368 | -4.5 Scores on a scale | Standard Error 0.22 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 6, n=359, 368 | -4.6 Scores on a scale | Standard Error 0.23 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 12, n=359, 368 | -5.2 Scores on a scale | Standard Error 0.23 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 15, n=359, 368 | -5.2 Scores on a scale | Standard Error 0.25 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 21, n=359, 368 | -5.5 Scores on a scale | Standard Error 0.25 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 24, n=359, 368 | -5.4 Scores on a scale | Standard Error 0.25 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 24, n=359, 368 | -3.6 Scores on a scale | Standard Error 0.25 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 12, n=359, 368 | -3.6 Scores on a scale | Standard Error 0.23 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 21, n=359, 368 | -3.6 Scores on a scale | Standard Error 0.24 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 1, n=358, 367 | -0.9 Scores on a scale | Standard Error 0.2 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 15, n=359, 368 | -3.6 Scores on a scale | Standard Error 0.24 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 3, n=359, 368 | -2.4 Scores on a scale | Standard Error 0.22 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 18, n=359, 368 | -3.3 Scores on a scale | Standard Error 0.25 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 6, n=359, 368 | -3.2 Scores on a scale | Standard Error 0.22 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach | Month 9, n=359, 368 | -3.6 Scores on a scale | Standard Error 0.22 |
p-value: <0.00195% CI: [-2.8, -1.7]t-test, 2 sided
p-value: <0.00195% CI: [-2.7, -1.5]t-test, 2 sided
p-value: <0.00195% CI: [-2.1, -0.9]t-test, 2 sided
p-value: <0.00195% CI: [-2.2, -1]t-test, 2 sided
p-value: <0.00195% CI: [-2.2, -1]t-test, 2 sided
p-value: <0.00195% CI: [-2.3, -1]t-test, 2 sided
p-value: <0.00195% CI: [-2.4, -1]t-test, 2 sided
p-value: <0.00195% CI: [-2.5, -1.2]t-test, 2 sided
p-value: <0.00195% CI: [-2.5, -1.2]t-test, 2 sided
Secondary
Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, n=359, 368 | -2.1 Scores on a scale | Standard Error 0.12 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, n=359, 368 | -2.2 Scores on a scale | Standard Error 0.12 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, n=359, 368 | -1.9 Scores on a scale | Standard Error 0.11 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, n=359, 368 | -2.2 Scores on a scale | Standard Error 0.12 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, n=359, 368 | -1.8 Scores on a scale | Standard Error 0.11 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, n=359, 368 | -2.4 Scores on a scale | Standard Error 0.12 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, n=359, 368 | -2.1 Scores on a scale | Standard Error 0.11 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, n=359, 368 | -2.4 Scores on a scale | Standard Error 0.12 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, n=357, 366 | -1.3 Scores on a scale | Standard Error 0.11 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, n=359, 368 | -1.6 Scores on a scale | Standard Error 0.12 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, n=357, 366 | -0.4 Scores on a scale | Standard Error 0.11 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, n=359, 368 | -1.0 Scores on a scale | Standard Error 0.11 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, n=359, 368 | -1.3 Scores on a scale | Standard Error 0.11 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, n=359, 368 | -1.5 Scores on a scale | Standard Error 0.11 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, n=359, 368 | -1.5 Scores on a scale | Standard Error 0.12 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, n=359, 368 | -1.4 Scores on a scale | Standard Error 0.12 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, n=359, 368 | -1.6 Scores on a scale | Standard Error 0.12 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, n=359, 368 | -1.5 Scores on a scale | Standard Error 0.12 |
Secondary
Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Each participant was asked the following question If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. This response was rated from 0 (delighted) to 6 (terrible). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, n=359, 368 | -1.4 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, n=359, 368 | -1.3 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, n=359, 368 | -1.4 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, n=359, 368 | -1.2 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, n=359, 368 | -1.5 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, n=359, 368 | -1.3 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, n=359, 368 | -1.5 Scores on a scale | Standard Error 0.06 |
| Dutasteride Plus Tamsulosin | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, n=358, 367 | -0.8 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, n=358, 367 | -0.3 Scores on a scale | Standard Error 0.05 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, n=359, 368 | -0.7 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, n=359, 368 | -0.9 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, n=359, 368 | -1.0 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
| Watchful Waiting All: Escalated Yes and No | Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, n=359, 368 | -1.1 Scores on a scale | Standard Error 0.06 |
Secondary
Exposure to Study Drug
Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.
Time frame: Up to 2 years
Population: Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Exposure to Study Drug | 639.8 days | Standard Deviation 215.49 |
| Watchful Waiting All: Escalated Yes and No | Exposure to Study Drug | 566.3 days | Standard Deviation 195.13 |
Secondary
Number of Events of Clinical Progression (CP) of BPH
The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS \>=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.
Time frame: Up to 2 years
Population: ITT Population. Only those participants at risk for CP at the specified visit were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Events of Clinical Progression (CP) of BPH | Year 1, n=369, 373 | 48 Events |
| Dutasteride Plus Tamsulosin | Number of Events of Clinical Progression (CP) of BPH | Year 2, n=276, 251 | 17 Events |
| Watchful Waiting All: Escalated Yes and No | Number of Events of Clinical Progression (CP) of BPH | Year 2, n=276, 251 | 14 Events |
| Watchful Waiting All: Escalated Yes and No | Number of Events of Clinical Progression (CP) of BPH | Year 1, n=369, 373 | 94 Events |
Secondary
Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries
BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate \[TURP\], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.
Time frame: Up to Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with any BPH-related surgery | 6 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with 2 surgeries | 1 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with TURP | 2 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with cystoscopy | 5 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with prostatectomy | 0 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with >=3 surgeries | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with >=3 surgeries | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with prostatectomy | 1 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with 2 surgeries | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with cystoscopy | 1 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with TURP | 1 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries | Participants with any BPH-related surgery | 3 Participants |
Secondary
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization
A post-randomization adverse event is defined as an event with an onset on or after the randomization date or with a missing onset date. An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general non-serious AE/SAE module for a list of non-serious AEs (occurring at a frequency threshold of \>=5%) and SAEs.
Time frame: Up to 2 years
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any AE | 190 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any SAE | 38 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any AE | 119 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any SAE | 25 Participants |
| Watchful Waiting Escalated=Yes | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any AE | 95 Participants |
| Watchful Waiting Escalated=Yes | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Starting Post-randomization | Any SAE | 19 Participants |
Secondary
Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: \>=1 point through \>=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: \>0 percent, \>=10 percent, \>=20 percent, \>=25 percent, \>=30 percent, \>=40 percent, and \>=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: \>=2 points, \>=3 points, and percent change \>=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=3 points, n=359, 368 | 261 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=25 percent, n=359, 368 | 247 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=25 percent, n=358, 367 | 161 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=3 points, n=359, 368 | 259 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=2 points, n=359, 368 | 277 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=25 percent, n= 359, 368 | 249 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=25 percent, 359, 368 | 245 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=2 points, n=359, 368 | 289 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=3 points, n=359, 368 | 233 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=2 points, n=359, 368 | 286 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=25 percent, n=359, 368 | 245 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=25 percent, n= 359, 368 | 218 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=2 points, n=359, 368 | 288 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=3points, n=359, 368 | 277 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=3 points, n=359, 368 | 262 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=2 points, n=359, 368 | 277 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=2 points, n=358, 367 | 225 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=2 points, n=359, 368 | 292 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=3 points, n=359, 368 | 245 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=3 points, n=359, 368 | 267 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=2 points, n=359, 368 | 291 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=25 percent, n= 359, 368 | 253 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=2 points, n=359, 368 | 295 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=25 percent, n=359, 368 | 229 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=3 points, n=359, 368 | 257 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=25 percent, n= 359, 368 | 261 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=3 points, n=358, 367 | 182 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=25 percent, n= 359, 368 | 221 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=25 percent, n=359, 368 | 189 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=2 points, n=359, 368 | 276 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=25 percent, n= 359, 368 | 224 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=2 points, n=358, 367 | 149 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=3 points, n=358, 367 | 90 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, >=25 percent, n=358, 367 | 76 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=2 points, n=359, 368 | 221 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=3 points, n=359, 368 | 172 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, >=25 percent, n= 359, 368 | 150 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=2 points, n=359, 368 | 250 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, >=3 points, n=359, 368 | 208 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=3 points, n=359, 368 | 222 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, >=25 percent, n=359, 368 | 207 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=2 points, n=359, 368 | 273 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=3 points, n=359, 368 | 229 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, >=25 percent, n= 359, 368 | 214 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=2 points, n=359, 368 | 275 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=3 points, n=359, 368 | 243 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, >=25 percent, n=359, 368 | 231 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=2 points, n=359, 368 | 268 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=3 points, n=359, 368 | 229 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, >=25 percent, 359, 368 | 212 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=2 points, n=359, 368 | 274 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, >=3 points, n=359, 368 | 237 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=2 points, n=359, 368 | 279 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, >=3points, n=359, 368 | 234 Participants |
Secondary
Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH
CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS \>=3 points from Baseline \[Visit 2\]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components (Tied for first component), and the number of participants with multiple first-occurring components were summarized by treatment group.
Time frame: Up to Month 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH symptom progression, n=65, 108 | 59 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related renal insufficiency, n=65, 108 | 0 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related AUR, n=65, 108 | 2 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Tied for first component, n=65, 108 | 0 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (>=4 components), n=65, 108 | 0 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (2 components), n=65, 108 | 4 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related incontinence, n=65, 108 | 4 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (3 components), n=65, 108 | 0 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Participants with CP of BPH, n=369, 373 | 65 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Recurrent BPH-related UTI, n=65, 108 | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (>=4 components), n=65, 108 | 1 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH symptom progression, n=65, 108 | 97 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related AUR, n=65, 108 | 4 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related incontinence, n=65, 108 | 3 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Recurrent BPH-related UTI, n=65, 108 | 4 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | BPH-related renal insufficiency, n=65, 108 | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Tied for first component, n=65, 108 | 0 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (2 components), n=65, 108 | 9 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Multiple components (3 components), n=65, 108 | 1 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH | Participants with CP of BPH, n=369, 373 | 108 Participants |
Secondary
Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: Overall, how satisfied are you with the treatment and its effect on your urinary problems? There were seven possible responses, including: very satisfied, satisfied, somewhat satisfied, neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied. Response categories were created by grouping together very satisfied, satisfied, and somewhat satisfied responses into the category of Any Satisfaction (AS), and separately grouping neutral, somewhat dissatisfied, dissatisfied, and very dissatisfied responses into the category of Neutral or Any Dissatisfaction (N/AD). The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Neutral/Any Dissatisfaction, n=358, 349 | 86 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Any Satisfaction, n=359, 361 | 304 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Neutral/Any Dissatisfaction, n=315, 328 | 196 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Neutral/Any Dissatisfaction, n= 359, 361 | 55 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Any Satisfaction, n= 359, 359 | 300 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Any Satisfaction, n=359, 363 | 311 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Neutral/Any Dissatisfaction, n=359, 364 | 47 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Neutral/Any Dissatisfaction, n=359, 363 | 48 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Neutral/Any Dissatisfaction, n=359, 359 | 59 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Any Satisfaction, n=359, 364 | 311 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Neutral/Any Dissatisfaction, n=359, 364 | 48 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Any Satisfaction, n=359, 364 | 305 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Any Satisfaction, n=358, 349 | 272 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Neutral/Any Dissatisfaction, n=359, 364 | 54 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Any Satisfaction, n=359, 361 | 301 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Any Satisfaction, n=359, 364 | 310 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Neutral/Any Dissatisfaction, n=359, 364 | 49 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Any Satisfaction, n=359, 364 | 312 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Neutral /Any Dissatisfaction, n=359, 361 | 58 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Any Satisfaction, n=315, 328 | 119 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Neutral/Any Dissatisfaction, n=359, 364 | 52 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Any Satisfaction, n=359, 364 | 299 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Neutral/Any Dissatisfaction, n=359, 364 | 65 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Any Satisfaction, n=359, 364 | 300 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Any Satisfaction, n=315, 328 | 122 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Neutral/Any Dissatisfaction, n=315, 328 | 206 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Any Satisfaction, n=358, 349 | 209 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Neutral/Any Dissatisfaction, n=358, 349 | 140 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Any Satisfaction, n= 359, 359 | 265 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Neutral/Any Dissatisfaction, n=359, 359 | 94 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Any Satisfaction, n=359, 361 | 285 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Neutral /Any Dissatisfaction, n=359, 361 | 76 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Any Satisfaction, n=359, 361 | 293 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Neutral/Any Dissatisfaction, n= 359, 361 | 68 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Any Satisfaction, n=359, 363 | 305 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Neutral/Any Dissatisfaction, n=359, 363 | 58 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Any Satisfaction, n=359, 364 | 298 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Neutral/Any Dissatisfaction, n=359, 364 | 66 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Neutral/Any Dissatisfaction, n=359, 364 | 64 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Any Satisfaction, n=359, 364 | 312 Participants |
Secondary
Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach
The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: Would you ask your doctor for the treatment you received in this study? There were three possible responses, including: Yes, No, and Not sure. Response categories included Yes and No or Not Sure, created by grouping together No and Not sure. The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Time frame: Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24
Population: ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Yes, n=358, 347 | 224 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Yes, n=359, 363 | 240 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, No or Not Sure, n=359, 357 | 127 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, No or Not Sure, n=315, 328 | 206 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Yes, n=359, 364 | 246 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Yes, n=359, 360 | 232 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, No or Not Sure, n=359, 364 | 113 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, No or Not Sure, n=358, 347 | 134 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Yes, n=359, 364 | 235 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, No or Not Sure, n=359, 360 | 127 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, No or Not Sure, n=359, 364 | 124 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Yes, n=315, 328 | 109 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Yes, n=359, 364 | 249 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Yes, n=359, 361 | 238 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, No or Not Sure, n=359, 364 | 110 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Yes, n=359, 357 | 232 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Yes, n=359, 364 | 243 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, No or Not Sure, n=359, 361 | 121 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, No or Not Sure, n=359, 364 | 116 Participants |
| Dutasteride Plus Tamsulosin | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, No or Not Sure, n=359, 363 | 119 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, No or Not Sure, n=359, 364 | 128 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, Yes, n=315, 328 | 103 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Baseline, No or Not Sure, n=315, 328 | 225 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, Yes, n=358, 347 | 166 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 1, No or Not Sure, n=358, 347 | 181 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, Yes, n=359, 357 | 207 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 3, No or Not Sure, n=359, 357 | 150 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, Yes, n=359, 360 | 227 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 6, No or Not Sure, n=359, 360 | 133 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, Yes, n=359, 361 | 231 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 9, No or Not Sure, n=359, 361 | 130 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, Yes, n=359, 363 | 229 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 12, No or Not Sure, n=359, 363 | 134 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, Yes, n=359, 364 | 239 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 15, No or Not Sure, n=359, 364 | 125 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, Yes, n=359, 364 | 236 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 18, No or Not Sure, n=359, 364 | 128 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, Yes, n=359, 364 | 234 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 21, No or Not Sure, n=359, 364 | 130 Participants |
| Watchful Waiting All: Escalated Yes and No | Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach | Month 24, Yes, n=359, 364 | 236 Participants |