A Trial to Investigate Efficacy, Safety and Tolerability... | NCT03201419 | Trialant
NCT03201419
Sponsor
Ferring Pharmaceuticals
Status
Completed
Last Update Posted
Mar 2, 2022Actual
Enrollment
302Actual
Phase
Phase 2
Conditions
Nocturia
Interventions
FE 201836
Desmopressin
Placebo oral solution
Placebo ODT
Countries
United States
Belgium
Canada
Czechia
Germany
Hungary
Poland
Protocol Section
Identification Module
NCT ID
NCT03201419
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
000233
Secondary IDs
ID
Type
Description
Link
2016-003851-31
EudraCT Number
Brief Title
A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults
Official Title
A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
Acronym
Not provided
Organization
Ferring PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Oct 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 27, 2017Actual
Primary Completion Date
Oct 31, 2019Actual
Completion Date
Oct 31, 2019Actual
First Submitted Date
Jun 26, 2017
First Submission Date that Met QC Criteria
Jun 26, 2017
First Posted Date
Jun 28, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Oct 28, 2020
Results First Submitted that Met QC Criteria
Nov 26, 2020
Results First Posted Date
Dec 23, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 17, 2022
Last Update Posted Date
Mar 2, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
Detailed Description
Not provided
Conditions Module
Conditions
Nocturia
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
302Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
FE 201836 500 μg (Randomized Treatment Period)
Experimental
FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
Drug: FE 201836
Drug: Placebo ODT
FE 201836 350 μg (Randomized Treatment Period)
Experimental
FE 201836 350 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Drug: Placebo ODT
FE 201836 250 μg (Randomized Treatment Period)
Experimental
FE 201836 250 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Drug: Placebo ODT
FE 201836 150 μg (Randomized Treatment Period)
Experimental
FE 201836 150 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Drug: Placebo ODT
FE 201836 100 μg (Randomized Treatment Period)
Experimental
FE 201836 100 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Drug: Placebo ODT
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FE 201836
Drug
Oral solution for daily intake
FE 201836 100 μg (Randomized Treatment Period)
FE 201836 150 μg (Randomized Treatment Period)
FE 201836 250 μg (Randomized Treatment Period)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
Baseline, during 12 weeks of treatment
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
MMRM=Mixed Model for Repeated Measurements.
For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adults ≥18 years of age (at the time of written consent)
Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3
Exclusion Criteria:
Current diagnosis of Obstructive Sleep Apnoea (OSA)
Restless Legs Syndrome (RLS)
Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
Habitual (fluid intake >3L per day) or psychogenic polydipsia
Uncontrolled hypertension, as judged by the investigator
Uncontrolled diabetes mellitus, as judged by the investigator
Central or nephrogenic diabetes insipidus
Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
History of gastric retention
Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
Hyponatraemia:
Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
Use of any prohibited therapy listed below:
Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
Hudgens S, Howerter A, Polek E, Andersson FL. Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting. Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 1721 subjects were screened, wherein, 531 met the eligibility criteria and entered the enrichment period. Of these, 302 subjects met the eligibility criteria at Visit (V) 4 (randomization), and were randomized to treatment with FE 201836 (different doses), placebo, or desmopressin. A total of 278 subjects completed the trial.
Recruitment Details
A total of 71 sites were authorized to recruit subjects for the trial between July 2017 and July 2019. The trial sites that screened subjects to the trial were: 5 in Belgium, 10 in Canada, 5 in Czech Republic, 2 in Germany, 5 in Hungary, 1 in Poland and 43 in the Unites States of America (USA).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
FE 201836 500 µg (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo orally disintegrating tablet (ODT), administered once daily
FG001
FE 201836 350 µg (Randomized Treatment Period)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 5, 2018
Oct 28, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The trial consisted of a 2 week period of screening/lifestyle changes during which no treatment was given, a 2 week enrichment period (including a 1 week single blind active run-in period [FE 201836 500 µg] and a 1 week washout period) followed by a 12 week randomized treatment period for each subject. Prior to the first interim analysis, the first 129 subjects were randomized to daily treatment with FE 201836 500 µg, placebo, or desmopressin (25 µg for females and 50 µg for males) in a 2:2:1 ratio. After the first interim analysis, subjects were randomized to daily treatment with FE 201836 (50 µg, 100 µg, 150 µg, 250 µg, 350 µg, or 500 µg), placebo, or desmopressin (25 µg for females and 50 µg for males) using response adaptive allocation probabilities.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Each subject will receive 2 medications (an oral solution and an orally disintegrating tablet (ODT) formulation) throughout the trial, in order to keep the treatment blinded.
Who Masked
ParticipantInvestigator
FE 201836 50 μg (Randomized Treatment Period)
Experimental
FE 201836 50 μg oral solution and placebo ODT, administered once daily
Drug: FE 201836
Drug: Placebo ODT
Placebo (Randomized Treatment Period)
Experimental
Placebo oral solution and placebo ODT, administered once daily
Drug: Placebo oral solution
Drug: Placebo ODT
Desmopressin 25 μg (Randomized Treatment Period)
Experimental
Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects)
Drug: Desmopressin
Drug: Placebo oral solution
Desmopressin 50 μg (Randomized Treatment Period)
Experimental
Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects)
Drug: Desmopressin
Drug: Placebo oral solution
FE 201836 350 μg (Randomized Treatment Period)
FE 201836 50 μg (Randomized Treatment Period)
FE 201836 500 μg (Randomized Treatment Period)
Velmupressin
Desmopressin
Drug
Desmopressin Orally Disintegrating Tablet (ODT)
Desmopressin 25 μg (Randomized Treatment Period)
Desmopressin 50 μg (Randomized Treatment Period)
NOCDURNA
Placebo oral solution
Drug
Manufactured to mimic experimental drug
Desmopressin 25 μg (Randomized Treatment Period)
Desmopressin 50 μg (Randomized Treatment Period)
Placebo (Randomized Treatment Period)
Placebo ODT
Drug
Manufactured to mimic experimental drug
FE 201836 100 μg (Randomized Treatment Period)
FE 201836 150 μg (Randomized Treatment Period)
FE 201836 250 μg (Randomized Treatment Period)
FE 201836 350 μg (Randomized Treatment Period)
FE 201836 50 μg (Randomized Treatment Period)
FE 201836 500 μg (Randomized Treatment Period)
Placebo (Randomized Treatment Period)
Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 1
Responder Rate in Nocturnal Voids at Week 4
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 4
Responder Rate in Nocturnal Voids at Week 8
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 8
Responder Rate in Nocturnal Voids at Week 12
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Week 12
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Defined as 50% reduction in nocturnal voids from baseline.
Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
During 12 weeks of treatment
Change From Baseline in Mean NI Diary Total Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 1
Change From Baseline in Mean NI Diary Total Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 4
Change From Baseline in Mean NI Diary Total Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 8
Change From Baseline in Mean NI Diary Total Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, during 12 weeks of treatment
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
During 12 weeks of treatment
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
During 12 weeks of treatment
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 1
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 4
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 8
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, during 12 weeks of treatment
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 1
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 4
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 8
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in PGI-S Scores at Week 4
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in PGI-S Scores at Week 8
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in PGI-S Scores at Week 12
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in ISI at Week 4
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 4
Change From Baseline in ISI at Week 8
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 8
Change From Baseline in ISI at Week 12
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 1
Change From Baseline in Mean Duration of FUSP at Week 4
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 4
Change From Baseline in Mean Duration of FUSP at Week 8
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 8
Change From Baseline in Mean Duration of FUSP at Week 12
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Baseline, Week 12
Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Baseline, During 12 Weeks of Treatment
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Baseline, Week 1
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Baseline, Week 12
Change From Baseline in Mean NUV in Week 1
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Baseline, Week 1
Change From Baseline in Mean NUV at Week 12
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Baseline, Week 12
Mobile
Alabama
36608
United States
Clinical Trials Research
Lincoln
California
95648
United States
Tri Valley Urology Medical Group
Murrieta
California
92562
United States
San Diego Clinical Trials
San Diego
California
92120
United States
Advanced Rx Clinical Research Group, Inc.
Westminster
California
92683
United States
Downtown Women's Health Care
Denver
Colorado
80209
United States
Genitourinary Surgical Consultants, P.C.
Denver
Colorado
80220
United States
South Florida Medical Research
Aventura
Florida
33180
United States
Women's Medical Research Group, LLC
Clearwater
Florida
33759
United States
Tampa Bay Medical Research, Inc.
Clearwater
Florida
33761
United States
Clinical Research of South Florida
Coral Gables
Florida
33134
United States
Avail Clinical Research, LLC
DeLand
Florida
32720
United States
Finlay Medical Research Corp
Greenacres City
Florida
33467
United States
Pharmax Research Clinic
Miami
Florida
33126
United States
Doctors Research Institute Corporation
Miami
Florida
33145
United States
Sanitas Research
Miami
Florida
33155
United States
Bayside Clinical Research LLC
New Port Richey
Florida
34655
United States
Pines Care Research Center, Inc
Pembroke Pines
Florida
33026
United States
Clinical Research Center of Florida
Pompano Beach
Florida
33060
United States
Meridien Research, Inc.
St. Petersburg
Florida
33709
United States
American Health Network of Indiana, LLC
Avon
Indiana
46123
United States
American Health Network of Indiana, LLC
Greenfield
Indiana
46140
United States
Bay State Clinical Trials, Inc.
Watertown
Massachusetts
02472
United States
Beyer Research
Kalamazoo
Michigan
49009
United States
Remedica LLC
Rochester
Michigan
48307
United States
Quality Clinical Research Center, Inc.
Omaha
Nebraska
68114
United States
Clinical Research Consortium, an AMR company
Las Vegas
Nevada
89119-5190
United States
Mid Hudson Medical Research, PLLC
New Windsor
New York
12553
United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie
New York
12601
United States
American Health Research, Inc.
Charlotte
North Carolina
28207
United States
Medication Management, LLC
Greensboro
North Carolina
27408
United States
Peters Medical Research
High Point
North Carolina
27262
United States
PMG Research of Raleigh, LLC
Raleigh
North Carolina
27609
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28401
United States
HWC Women's Research Center
Englewood
Ohio
45322
United States
NECCR Primacare Research, LLC
Providence
Rhode Island
02908
United States
Coastal Carolina Research Center, Inc
Mt. Pleasant
South Carolina
29464
United States
PMG Research of Charleston, LLC
Mt. Pleasant
South Carolina
29464
United States
MCA Research - Partner
Houston
Texas
77079
United States
Ericksen Research & Development, LLC
Clinton
Utah
84015
United States
Advanced Research Institute
Ogden
Utah
84405
United States
Clinical Research Associates of Tidewater, an AMR company
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Urologia
NyÃregyháza
Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok
Hungary
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz
Poland
FE 201836 350 µg oral solution and placebo ODT, administered once daily
FG002
FE 201836 250 µg (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
FG003
FE 201836 150 µg (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
FG004
FE 201836 100 µg (Randomized Treatment Period)
FE 201836 100 µg oral solution and placebo ODT, administered once daily
FG005
FE 201836 50 µg (Randomized Treatment Period)
FE 201836 50 µg oral solution and placebo ODT, administered once daily
FG006
Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
FG007
Desmopressin 25 µg (Randomized Treatment Period)
Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
FG008
Desmopressin 50 µg (Randomized Treatment Period)
Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
FG00060 subjects
FG00127 subjects
FG00224 subjects
FG00314 subjects
FG00413 subjects
FG00534 subjects
FG00687 subjects
FG00726 subjects
FG00817 subjects
COMPLETED
FG00052 subjects
FG00124 subjects
FG00222 subjects
FG00314 subjects
FG00412 subjects
FG00533 subjects
FG00681 subjects
FG00725 subjects
FG00815 subjects
NOT COMPLETED
FG0008 subjects
FG0013 subjects
FG0022 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0066 subjects
FG0071 subjects
FG0082 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FE 201836 500 µg (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
BG001
FE 201836 350 µg (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
BG002
FE 201836 250 µg (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
BG003
FE 201836 150 µg (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
BG004
FE 201836 100 µg (Randomized Treatment Period)
FE 201836 100 µg oral solution and placebo ODT, administered once daily
BG005
FE 201836 50 µg (Randomized Treatment Period)
FE 201836 50 µg oral solution and placebo ODT, administered once daily
BG006
Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
BG007
Desmopressin 25µg (Randomized Treatment Period)
Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
BG008
Desmopressin 50 µg (Randomized Treatment Period)
Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00060
BG00127
BG00224
BG00314
BG00413
BG00534
BG00687
BG00726
BG00817
BG009302
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00127
ParticipantsBG00224
ParticipantsBG003
Age, Customized
Number
years
Title
Denominators
Categories
<65 years old
ParticipantsBG00060
ParticipantsBG00127
ParticipantsBG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00127
ParticipantsBG002
Ethnicity (NIH/OMB)
Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00059
ParticipantsBG00127
ParticipantsBG002
Race (NIH/OMB)
Number analyzed differs from the overall population as baseline race was not reported for some of the subjects.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00127
ParticipantsBG002
Baseline body mass index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00127
ParticipantsBG002
Mean Number of Nocturnal Voids
Number analyzed differs from the overall population as baseline mean number of nocturnal voids was not calculated for some of the subjects.
Mean
Standard Deviation
nocturnal voids
Title
Denominators
Categories
ParticipantsBG00059
ParticipantsBG00127
ParticipantsBG002
Mean Nocturnal Urine Volume (NUV)
Number analyzed differs from the overall population as baseline mean NUV was not calculated for some of the subjects.
Mean
Standard Deviation
mL
Title
Denominators
Categories
ParticipantsBG00058
ParticipantsBG00126
ParticipantsBG002
Mean Nocturnal Polyuria Index
Nocturnal polyuria index (NPi) is calculated by dividing the nocturnal urine volume (NUV) by the 24-hour urine volume. In this clinical trial the NPi definition >33% is used for all ages to define presence of nocturnal polyuria (NP).
Number analyzed differs from the overall population as baseline mean nocturnal polyuria index was not calculated for some of the subjects.
Mean
Standard Deviation
percentage
Title
Denominators
Categories
ParticipantsBG00055
ParticipantsBG00125
Mean Nocturia Impact (NI) Diary Total Score
Number analyzed differs from the overall population as mean NI Diary Total Score was not calculated for some of the subjects.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG00126
ParticipantsBG002
Mean NI Diary Overall Impact Score
The Nocturia Impact (NI) Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall Quality-of-Life (QoL) impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Score is standardized from 0 to 100 (lowest to highest impact). The score at each visit was calculated as the average over the three consecutive 24-hour periods just prior to the respective visit.
Number analyzed differs from the overall population as mean NI Diary Overall Impact Score was not calculated for some of the subjects.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00060
ParticipantsBG001
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Number analyzed differs from the overall population as mean ISI was not calculated for some of the subjects.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00055
ParticipantsBG00126
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
The intention-to-treat analysis set for the randomized treatment period (ITT-RT) comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
nocturnal voids
Baseline, during 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
OG004
FE 201836 100 ug (Randomized Treatment Period)
FE 201836 100 µg oral solution and placebo ODT, administered once daily
OG005
FE 201836 50 ug (Randomized Treatment Period)
FE 201836 50 µg oral solution and placebo ODT, administered once daily
OG006
Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
Units
Counts
Participants
OG00060
OG00127
OG00224
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.06(-1.28 to -0.86)
OG001-0.99(-1.20 to -0.78)
OG002-0.89(-1.12 to -0.69)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG006
Based on a Bayesian analysis of a sigmoidal dose-response relationship.
Mean Difference
-0.30
2-Sided
95
-0.54
-0.07
Superiority
OG001
OG006
Based on a Bayesian analysis of a sigmoidal dose-response relationship.
Secondary
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
MMRM=Mixed Model for Repeated Measurements.
For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
nocturnal voids
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
Secondary
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
nocturnal voids
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
nocturnal voids
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
nocturnal voids
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Responder Rate in Nocturnal Voids at Week 1
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
odd of response
Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
Secondary
Responder Rate in Nocturnal Voids at Week 4
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
odd of response
Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
Secondary
Responder Rate in Nocturnal Voids at Week 8
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
odd of response
Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
Secondary
Responder Rate in Nocturnal Voids at Week 12
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
odd of response
Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
Secondary
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Defined as 50% reduction in nocturnal voids from baseline.
Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
odd of response
During 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean NI Diary Total Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Total Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Total Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Total Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Median
95% Confidence Interval
score on a scale
Baseline, during 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
Secondary
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
percentage of nights
During 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
percentage of nights
During 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Baseline, during 12 weeks of treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
Secondary
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
score on a scale
Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 μg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 μg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 μg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in PGI-S Scores at Week 4
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 μg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 μg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 μg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in PGI-S Scores at Week 8
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution for daily intake
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution for daily intake
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution for daily intake
OG003
FE 201836 150 ug (Randomized Treatment Period)
FE 201836 150 µg oral solution for daily intake
Secondary
Change From Baseline in PGI-S Scores at Week 12
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in ISI at Week 4
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in ISI at Week 8
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in ISI at Week 12
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Least Squares Mean
95% Confidence Interval
score on a scale
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
minutes
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Duration of FUSP at Week 4
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
minutes
Baseline, Week 4
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Duration of FUSP at Week 8
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
minutes
Baseline, Week 8
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean Duration of FUSP at Week 12
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
minutes
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
minutes
Baseline, During 12 Weeks of Treatment
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
Secondary
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
mL/min
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
mL/min
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean NUV in Week 1
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
mL
Baseline, Week 1
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Secondary
Change From Baseline in Mean NUV at Week 12
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
The ITT-RT comprised of all the subjects randomized at Visit 4.
Posted
Mean
95% Confidence Interval
mL
Baseline, Week 12
ID
Title
Description
OG000
FE 201836 500 ug (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
OG001
FE 201836 350 ug (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
OG002
FE 201836 250 ug (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
OG003
FE 201836 150 ug (Randomized Treatment Period)
Time Frame
Enrichment period: Treatment-emergent adverse events (AEs) occurring in the time interval from V2 (active run-in) to V4 (randomization), including AEs with missing start date. Randomized treatment period: Treatment-emergent AEs occurring in the time interval from V4 to end-of-trial.
Description
The Safety Analysis Set for the enrichment period comprised subjects who received investigational medicinal product (IMP) at V2 and did not return all IMP unused at/before V4. The Safety Analysis Set for the randomized treatment period comprised subjects who received IMP at V4 and did not return all IMP unused, and who had at least 1 safety assessment after V4.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
FE 201836 500 µg (Enrichment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
0
531
2
531
0
531
EG001
FE 201836 500 µg (Randomized Treatment Period)
FE 201836 500 µg oral solution and placebo ODT, administered once daily
0
60
1
60
16
60
EG002
FE 201836 350 µg (Randomized Treatment Period)
FE 201836 350 µg oral solution and placebo ODT, administered once daily
0
27
2
27
3
27
EG003
FE 201836 250 µg (Randomized Treatment Period)
FE 201836 250 µg oral solution and placebo ODT, administered once daily
0
24
1
24
3
24
EG004
FE 201836 150 µg (Randomized Treatment Period)
FE 201836 150 µg oral solution and placebo ODT, administered once daily
0
14
0
14
8
14
EG005
FE 201836 100 µg (Randomized Treatment Period)
FE 201836 100 µg oral solution and placebo ODT, administered once daily
0
13
1
13
5
13
EG006
FE 201836 50 µg (Randomized Treatment Period)
FE 201836 50 µg oral solution and placebo ODT, administered once daily
0
34
0
34
7
34
EG007
Placebo (Randomized Treatment Period)
Placebo oral solution and placebo ODT, administered once daily
0
87
2
87
16
87
EG008
Desmopressin 25 µg (Randomized Treatment Period)
Desmopressin 25 µg ODT and placebo oral solution, administered once daily (female subjects)
0
26
0
26
8
26
EG009
Desmopressin 50 µg (Randomized Treatment Period)
Desmopressin 50 µg ODT and placebo oral solution, administered once daily (male subjects)
0
17
0
17
9
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (20.0)
Systematic Assessment
EG0002 events2 affected531 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected27 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected14 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected34 at risk
EG0070 events0 affected87 at risk
EG0080 events0 affected26 at risk
EG0090 events0 affected17 at risk
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA (20.0)
Systematic Assessment
EG0001 events1 affected531 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected27 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected27 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected27 at risk
EG003
Serum sickness-like reaction
Immune system disorders
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0011 events1 affected60 at risk
EG0020 events0 affected27 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0020 events0 affected27 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected27 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected27 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (20.0)
Systematic Assessment
EG0000 events0 affected531 at risk
EG0010 events0 affected60 at risk
EG0021 events1 affected27 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)