Treatment of Neuropathic Pain Associated With Diabetic Pe... | NCT01496365 | Trialant
NCT01496365
Sponsor
Daiichi Sankyo
Status
Completed
Last Update Posted
Jan 5, 2021Actual
Enrollment
452Actual
Phase
Phase 2
Conditions
Diabetic Peripheral Neuropathy
Interventions
DS-5565 tablet
pregabalin capsule
Placebo tablet
placebo capsule
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01496365
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
DS5565-A-U201
Secondary IDs
Not provided
Brief Title
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Official Title
A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Acronym
Not provided
Organization
Daiichi SankyoINDUSTRY
Status Module
Record Verification Date
Dec 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
Nov 28, 2011Actual
Primary Completion Date
Sep 7, 2012Actual
Completion Date
Sep 7, 2012Actual
First Submitted Date
Dec 19, 2011
First Submission Date that Met QC Criteria
Dec 20, 2011
First Posted Date
Dec 21, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 3, 2020
Results First Submitted that Met QC Criteria
Dec 8, 2020
Results First Posted Date
Jan 5, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 7, 2014
Certification/Extension First Submitted that Passed QC Review
Feb 7, 2014
Certification/Extension First Posted Date
Mar 11, 2014Estimated
Last Update Submitted Date
Dec 8, 2020
Last Update Posted Date
Jan 5, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Daiichi SankyoINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Detailed Description
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.
There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.
Conditions Module
Conditions
Diabetic Peripheral Neuropathy
Keywords
Keywords: pain, diabetes, neuropathy
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
452Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
DS-5565 5mg nighttime
Experimental
DS-5565 5 mg/day (one 5 mg tablet at bedtime)
Drug: DS-5565 tablet
Drug: placebo capsule
DS-5565 10 mg at bedtime
Experimental
DS-5565 10 mg/day (one 10 mg tablet at bedtime)
Drug: DS-5565 tablet
Drug: placebo capsule
DS-5565 15 mg at bedtime
Experimental
DS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime)
Drug: DS-5565 tablet
Drug: placebo capsule
DS-5565 20 mg total per day
Experimental
DS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime)
Drug: DS-5565 tablet
Drug: placebo capsule
DS-5565 30 mg total per day
Experimental
DS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime)
Drug: DS-5565 tablet
Drug: placebo capsule
Pregabalin 300 mg total per day
Interventions
Name
Type
Description
Arm Group Labels
Other Names
DS-5565 tablet
Drug
5mg and 10mg tablets
DS-5565 10 mg at bedtime
DS-5565 15 mg at bedtime
DS-5565 20 mg total per day
DS-5565 30 mg total per day
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
Baseline up to Week 5 postdose, up to 10 months total follow up
Secondary Outcomes
Measure
Description
Time Frame
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age > 18 years of age
Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
Creatinine clearance > 60 mL/min (estimated using the Cockcroft-Gault equation)
Antidiabetic and other medications anticipated to remain stable and constant during the study period
Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
Exclusion Criteria:
Diagnosis of mononeuropathy
Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
Major psychiatric disorders
Have had a malignancy other than basal cell carcinoma within the past 2 years
At Visit 1, have a white blood cell count < 2500/mm3, neutrophil count < 1500/mm3, or platelet count < 100 x 103/mm3
Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease
Clinically significant findings on the Screening ECG
History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection
Amputations of body parts other than toes
Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin)
Known hypersensitivity to pregabalin or gabapentin
Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs
Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN
Skin conditions that could alter sensation
Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN
Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year
Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug
Pregnancy (as based on lab test results) or breast feeding
Laboratory values exceeding limits listed in Table 4.1 of the protocol
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Domenico Merante, MD
Daiichi Sankyo
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Birmingham
Alabama
35242
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Participants were randomized to 1 of 7 treatment groups which included placebo, pregabalin 150 mg BID, DS-5565 5 mg QD, DS-5565 10 mg QD, DS-5565 15 mg QD, DS-5565 10 mg BID, and DS-5565 15 mg BID.
Recruitment Details
A total of 452 participants who met all inclusion criteria and no exclusion criteria were enrolled and randomized in the study at 80 clinic sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants who were randomized to placebo.
FG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
Baseline up to Week 5 postdose, up to 10 months total follow up
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level.
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = "pain did not interfere with sleep" to 10 = "pain completely interfered with sleep" over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep.
Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3:
throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores.
Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain.
Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity.
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions.
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity.
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement.
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief.
Baseline up to Week 5 postdose, up to 10 months total follow up
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2).
Baseline up to Week 5 postdose, up to 10 months total follow up
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1.
From the time of signing the informed consent form (ICF) up to 10 months postdose
Huntsville
Alabama
35801
United States
Mesa
Arizona
85206
United States
Phoenix
Arizona
85023
United States
Phoenix
Arizona
85028
United States
Tucson
Arizona
85712
United States
Hot Springs
Arkansas
71913
United States
Little Rock
Arkansas
72205
United States
Buena Park
California
90620
United States
Burbank
California
91505
United States
Chino
California
91710
United States
Fresno
California
93726
United States
Huntington Beach
California
92648
United States
Lakewood
California
90712
United States
Lomita
California
90717
United States
Long Beach
California
90806
United States
Santa Monica
California
90404
United States
Walnut Creek
California
94598
United States
Boulder
Colorado
80304
United States
Colorado Springs
Colorado
80920
United States
Denver
Colorado
80209
United States
Golden
Colorado
80401
United States
Cromwell
Connecticut
06416
United States
Fairfield
Connecticut
06824
United States
Bradenton
Florida
34208
United States
Brooksville
Florida
34601
United States
Clearwater
Florida
33756
United States
Hallandale
Florida
33009
United States
Miami
Florida
33143
United States
Miami
Florida
33169
United States
New Port Richey
Florida
34217
United States
New Port Richey
Florida
34652
United States
Orlando
Florida
32806
United States
Sunrise
Florida
33351
United States
Columbus
Georgia
31909
United States
Gainesville
Georgia
30501
United States
Marietta
Georgia
30060
United States
Evansville
Indiana
44714
United States
Madisonville
Kentucky
42431
United States
Paducah
Kentucky
42003
United States
Hyattsville
Maryland
20782
United States
Brockton
Massachusetts
02301
United States
Farmington Hills
Michigan
48025
United States
Olive Branch
Mississippi
38654
United States
Florissant
Missouri
63031
United States
Kansas City
Missouri
64114
United States
St Louis
Missouri
63141
United States
Omaha
Nebraska
68131
United States
Las Vegas
Nevada
89106
United States
Las Vegas
Nevada
89119
United States
Las Vegas
Nevada
89123
United States
Albany
New York
12205
United States
Cincinnati
Ohio
45245
United States
Dayton
Ohio
45439
United States
Toledo
Ohio
43623
United States
Tulsa
Oklahoma
74104
United States
Duncansville
Pennsylvania
16635
United States
Greensburg
Pennsylvania
15601
United States
Warwick
Rhode Island
02886
United States
Charleston
South Carolina
29407
United States
Greer
South Carolina
29561
United States
Greer
South Carolina
29651
United States
Mt. Pleasant
South Carolina
29464
United States
Chattanooga
Tennessee
37411
United States
Austin
Texas
78731
United States
Dallas
Texas
75230
United States
Dallas
Texas
75231
United States
El Paso
Texas
79925
United States
Houston
Texas
77030
United States
San Antonio
Texas
78154
United States
San Antonio
Texas
78229
United States
Sugar Land
Texas
77478
United States
Norfolk
Virginia
23507
United States
Norfolk
Virginia
23510
United States
Richmond
Virginia
23249
United States
Virginia Beach
Virginia
23454
United States
Renton
Washington
98057
United States
Spokane
Washington
99207
United States
FG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
FG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
FG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
FG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
FG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
FG000112 subjects
FG00156 subjects
FG00257 subjects
FG00357 subjects
FG00457 subjects
FG00556 subjects
FG00657 subjects
COMPLETED
FG00097 subjects
FG00141 subjects
FG00251 subjects
FG00353 subjects
FG00444 subjects
FG00546 subjects
FG00651 subjects
NOT COMPLETED
FG00015 subjects
FG00115 subjects
FG0026 subjects
FG0034 subjects
FG00413 subjects
FG00510 subjects
FG0066 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0013 subjects
FG0023 subjects
FG0032 subjects
FG0045 subjects
FG0056 subjects
FG0064 subjects
Withdrawal by Subject
FG0006 subjects
FG0016 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Baseline and demographic characteristics are reported in All Enrolled participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants who were randomized to placebo.
BG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
BG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
BG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
BG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
BG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
BG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000112
BG00156
BG00257
BG00357
BG00457
BG00556
BG00657
BG007452
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.2± 9.57
BG00159.5± 9.40
BG00258.9± 9.85
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00056
BG00124
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG000112
BG00156
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
ADPS was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.86± 2.18
OG001-1.79± 2.27
OG002-2.04± 2.22
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
OG001
ANCOVA
0.8916
Least squares mean
-0.05
2-Sided
95
-0.81
0.70
Superiority
OG000
OG002
ANCOVA
0.5569
Secondary
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
ADPS was assessed in the Full Analysis Set.
Posted
Least Squares Mean
95% Confidence Interval
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
Secondary
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level.
ADPS was assessed in the Full Analysis Set.
Posted
Count of Participants
Participants
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
Secondary
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = "pain did not interfere with sleep" to 10 = "pain completely interfered with sleep" over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep.
ADSIS was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3:
throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores.
SF-MPQ sensory and affective scores were assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain.
SF-MPQ total score and VAS pain were assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
Secondary
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity.
SF-MPQ present pain intensity was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Secondary
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions.
Modified BPI was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity.
Modified BPI was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement.
Modified BPI was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
units on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Secondary
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief.
Modified BPI was assessed in the Full Analysis Set.
Posted
Mean
Standard Deviation
score on a scale
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
Secondary
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2).
PGIC was assessed in the Full Analysis Set.
Posted
Count of Participants
Participants
Baseline up to Week 5 postdose, up to 10 months total follow up
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Secondary
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1.
Safety events were assessed in the Safety Analysis Set.
Posted
Count of Participants
Participants
From the time of signing the informed consent form (ICF) up to 10 months postdose
ID
Title
Description
OG000
Placebo
Participants who were randomized to placebo.
OG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Time Frame
Treatment-emergent adverse events (TEAEs) were collected from the time of signing the informed consent form (ICF) up to 10 months postdose in the Safety Analysis Set.
Description
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug.
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
Placebo
Participants who were randomized to placebo.
0
108
1
108
48
108
EG001
Pregabalin 150 mg BID
Participants who were randomized to pregabalin 150 mg twice daily (BID).
0
50
0
50
30
50
EG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
0
55
2
55
29
55
EG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
0
56
3
56
28
56
EG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
0
53
2
53
30
53
EG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
0
56
1
56
33
56
EG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
0
57
0
57
36
57
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Renal failure acute
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG0030 affected56 at risk
EG0040 affected53 at risk
EG0050 affected56 at risk
EG0060 affected57 at risk
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dyskinesia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Coronary artery disease
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Liver function test abnormal
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0013 affected50 at risk
EG0020 affected55 at risk
EG0037 affected56 at risk
EG0046 affected53 at risk
EG0054 affected56 at risk
EG0069 affected57 at risk
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected108 at risk
EG0012 affected50 at risk
EG0026 affected55 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0014 affected50 at risk
EG0021 affected55 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0012 affected50 at risk
EG0020 affected55 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0011 affected50 at risk
EG0022 affected55 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected108 at risk
EG0010 affected50 at risk
EG0023 affected55 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0004 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0014 affected50 at risk
EG0022 affected55 at risk
EG003
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0012 affected50 at risk
EG0020 affected55 at risk
EG003
Weight increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0005 affected108 at risk
EG0014 affected50 at risk
EG0022 affected55 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Diabetic neuropathy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Crying
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dizziness exertional
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Essential tremor
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Formication
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Hypersomnia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Mental impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Migraine
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tremor
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Akathisia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Aphthous stomatitis
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Gait disturbance
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Generalised oedema
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Inflammation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Irritability
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Malaise
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Sluggishness
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tenderness
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Thirst
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Asthenia
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Chills
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Feeling hot
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gravitational oedema
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Influenza-like illness
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Local swelling
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood creatinine phosphokinase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0003 affected108 at risk
EG0012 affected50 at risk
EG0021 affected55 at risk
EG003
Blood glucose increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Positive rombergism
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Urine leukocyte esterase positive
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
White blood cell count increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood chloride decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood urine present
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Creatinine renal clearance abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Creatinine renal clearance decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Heart rate increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Tandem gait test abnormal
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Transaminases increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Troponin I increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Weight decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
White blood cells urine positive
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood pressure increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Blood urea increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0012 affected50 at risk
EG0020 affected55 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Localised infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Ear infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0005 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected108 at risk
EG0012 affected50 at risk
EG0021 affected55 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Plantar fascitiis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Joint lock
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Euphoric mood
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Abnormal behaviour
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Anger
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0021 affected55 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Back injury
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0004 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Orthopnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Vision blurred
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0012 affected50 at risk
EG0021 affected55 at risk
EG003
Asthenopia
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dry eye
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Retinal tear
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Visual impairment
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Hot flush
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0022 affected55 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Pyuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Acute prerenal failure
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0021 affected55 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0011 affected50 at risk
EG0020 affected55 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Benign neoplasm of adrenal gland
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected108 at risk
EG0010 affected50 at risk
EG0020 affected55 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Contact for Clinical Trial Information
Daiichi Sankyo
908-992-6400
CTRinfo@dsi.com
ID
Term
D003920
Diabetes Mellitus
Ancestor Terms
ID
Term
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000598618
mirogabalin
D000069583
Pregabalin
Ancestor Terms
ID
Term
D005680
gamma-Aminobutyric Acid
D000613
Aminobutyrates
D002087
Butyrates
D000144
Acids, Acyclic
D002264
Carboxylic Acids
D009930
Organic Chemicals
D000596
Amino Acids
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0052 subjects
FG0061 subjects
0 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0051 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0061 subjects
60.9
± 9.92
BG00461.4± 8.70
BG00560.4± 8.59
BG00659.3± 8.54
BG00760.1± 9.26
30
BG00328
BG00423
BG00524
BG00625
BG007210
Male
BG00056
BG00132
BG00227
BG00329
BG00434
BG00532
BG00632
BG007242
0
BG0031
BG0040
BG0050
BG0060
BG0072
Asian
BG0003
BG0011
BG0020
BG0034
BG0041
BG0051
BG0061
BG00711
Native Hawaiian or Other Pacific Islander
BG0000
BG0012
BG0020
BG0030
BG0040
BG0051
BG0061
BG0074
Black or African American
BG00027
BG00117
BG00211
BG0039
BG00412
BG00510
BG0068
BG00794
White
BG00081
BG00136
BG00245
BG00343
BG00444
BG00544
BG00646
BG007339
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
BG0072
57
BG00357
BG00457
BG00556
BG00657
BG007452
56
OG00451
OG00556
OG00657
-2.32
± 2.17
OG004-2.66± 2.37
OG005-2.64± 2.45
OG006-2.79± 2.43
Least squares mean
-0.22
2-Sided
95
-0.95
0.51
Superiority
OG000
OG003
ANCOVA
0.1544
Least squares mean
-0.53
2-Sided
95
-1.25
0.20
Superiority
OG000
OG004
ANCOVA
0.0137
Least squares mean
-0.94
2-Sided
95
-1.69
-0.19
Superiority
OG000
OG005
ANCOVA
0.0171
Least squares mean
-0.88
2-Sided
95
-1.61
0.16
Superiority
OG000
OG006
ANCOVA
0.0060
Least square means
-1.01
2-Sided
95
-1.74
-0.29
Superiority
OG001
OG002
ANCOVA
0.7051
Least squares mean
-0.17
2-Sided
95
-1.03
0.69
Superiority
OG001
OG003
ANCOVA
0.2772
Least squares mean
-0.47
2-Sided
95
-1.33
0.38
Superiority
OG001
OG004
ANCOVA
0.0458
Least squares mean
-0.89
2-Sided
95
-1.77
-0.02
Superiority
OG001
OG005
ANCOVA
0.0569
Least squares mean
-0.83
2-Sided
95
-1.69
0.02
Superiority
OG001
OG006
ANCOVA
0.0271
Least squares mean
-0.96
2-Sided
95
-1.81
-0.11
Superiority
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Week 1
ParticipantsOG000108
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00356
ParticipantsOG00451
ParticipantsOG00556
ParticipantsOG00657
Title
Measurements
OG000-0.55(-0.81 to -0.29)
OG001-1.10(-1.49 to -0.72)
OG002-0.68(-1.04 to -0.31)
OG003
Week 2
ParticipantsOG000106
ParticipantsOG00148
ParticipantsOG00255
ParticipantsOG00354
Week 3
ParticipantsOG000102
ParticipantsOG00145
ParticipantsOG00253
ParticipantsOG00354
Week 4
ParticipantsOG000100
ParticipantsOG00144
ParticipantsOG00252
ParticipantsOG00353
End of treatment
ParticipantsOG00097
ParticipantsOG00141
ParticipantsOG00251
ParticipantsOG00353
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Responder rate: ≥30% decrease from baseline
Title
Measurements
Yes
OG00045
OG00119
OG00222
OG00332
OG00434
OG00534
OG00632
No
OG00063
OG00131
OG00233
OG00324
OG004
Responder Rate: ≥50% decrease from baseline
Title
Measurements
Yes
OG00026
OG00114
OG00211
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00450
OG00556
OG00657
Title
Denominators
Categories
Title
Measurements
OG000-1.98± 2.38
OG001-1.94± 2.08
OG002-2.19± 2.35
OG003-2.35± 2.31
OG004-2.97± 2.57
OG005-2.52± 2.89
OG006-2.69± 2.43
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Sensory score
ParticipantsOG000108
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00356
ParticipantsOG00451
ParticipantsOG00555
ParticipantsOG00656
Title
Measurements
OG000-6.29± 6.77
OG001-5.94± 7.32
OG002-8.02± 6.62
OG003
Affective score
ParticipantsOG000108
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00355
OG002
DS-5565 5mg QD
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00355
OG00451
OG00555
OG00656
Title
Denominators
Categories
Total score
Title
Measurements
OG000-8.39± 8.91
OG001-7.92± 9.89
OG002-10.36± 8.54
OG003-11.16± 9.29
OG004-8.71± 8.11
OG005-7.96± 9.77
OG006-10.79± 8.94
VAS pain
Title
Measurements
OG000-20.84± 25.12
OG001-19.28± 24.27
OG002-27.40± 22.52
OG003
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Title
Measurements
OG000-0.85± 1.21
OG001-0.84± 0.96
OG002-1.00± 0.86
OG003-1.04± 1.23
OG004-0.90± 1.03
OG005-0.73± 1.34
OG006-1.02± 1.15
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 2.11
OG001-1.7± 1.83
OG002-1.6± 1.97
OG003-2.5± 2.11
OG004-2.4± 2.35
OG005-2.1± 2.51
OG006-2.6± 2.34
Participants who were randomized to DS-5565 5 mg every day (QD).
OG003
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Worst Pain Intensity
ParticipantsOG000107
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00355
ParticipantsOG00451
ParticipantsOG00555
ParticipantsOG00657
Title
Measurements
OG000-2.1± 2.53
OG001-1.9± 2.61
OG002-2.0± 2.26
OG003
Least Pain Intensity
ParticipantsOG000107
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00355
Average Pain Intensity
ParticipantsOG000107
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00355
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 2.35
OG001-1.8± 1.94
OG002-2.0± 2.13
OG003-2.5± 2.44
OG004-2.5± 2.36
OG005-2.0± 3.09
OG006-2.5± 2.75
DS-5565 10 mg QD
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Title
Measurements
OG00026.4± 37.67
OG00120.4± 31.06
OG00231.5± 34.72
OG00332.0± 36.33
OG00423.0± 37.39
OG00535.3± 33.13
OG00633.0± 43.52
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00451
OG00556
OG00657
Title
Denominators
Categories
Overall status is much improved or better (score ≤2)
ParticipantsOG000106
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG00355
ParticipantsOG00450
ParticipantsOG00552
ParticipantsOG00656
Title
Measurements
Yes
OG00033
OG00119
OG00227
OG003
Overall status is minimally improved or better (score ≤3)
ParticipantsOG000106
ParticipantsOG00150
ParticipantsOG00255
ParticipantsOG003
Participants who were randomized to DS-5565 10 mg every day (QD).
OG004
DS-5565 15 mg QD
Participants who were randomized to DS-5565 15 mg every day (QD).
OG005
DS-5565 10 mg BID
Participants who were randomized to DS-5565 10 mg twice daily (BID).
OG006
DS-5565 15 mg BID
Participants who were randomized to DS-5565 15 mg twice daily (BID).
Units
Counts
Participants
OG000108
OG00150
OG00255
OG00356
OG00453
OG00556
OG00657
Title
Denominators
Categories
Drug-related TEAEs
Title
Measurements
OG00031
OG00135
OG00224
OG00321
OG00440
OG00534
OG00637
Participants with ≥1 drug-related TEAEs
Title
Measurements
OG00020
OG00114
OG00213
OG003
Nervous System Disorders
Title
Measurements
OG0003
OG0017
OG0024
OG003
Dizziness
Title
Measurements
OG0001
OG0011
OG0020
OG003
Somnolence
Title
Measurements
OG0001
OG0014
OG0021
OG003
Headache
Title
Measurements
OG0001
OG0010
OG0023
OG003
Balance disorder
Title
Measurements
OG0000
OG0012
OG0020
OG003
Amnesia
Title
Measurements
OG0000
OG0010
OG0020
OG003
General Disorders & Administration Site Conditions