A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED) | NCT00758680 | Trialant
NCT00758680
Sponsor
Merck Sharp & Dohme LLC
Status
Terminated
Last Update Posted
Feb 5, 2016Estimated
Enrollment
112Actual
Phase
Phase 1
Conditions
Type 2 Diabetes
Interventions
MK-1006
Comparator: Placebo comparator
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00758680
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1006-004
Secondary IDs
ID
Type
Description
Link
2008_550
Brief Title
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
Official Title
A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1006.
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2016
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2008
Primary Completion Date
Mar 2010Actual
Completion Date
Mar 2010Actual
First Submitted Date
Sep 23, 2008
First Submission Date that Met QC Criteria
Sep 23, 2008
First Posted Date
Sep 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 24, 2012
Results First Submitted that Met QC Criteria
Jul 24, 2012
Results First Posted Date
Aug 28, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 4, 2016
Last Update Posted Date
Feb 5, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
This study will asses the safety, tolerability, multiple-dose pharmacokinetics and pharmacodynamics of MK1006 in participants with type 2 diabetes.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MK-1006 20 mg Once Daily (Panel A)
Experimental
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
Drug: MK-1006
MK-1006 40 mg Once Daily (Panel B)
Experimental
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Drug: MK-1006
MK-1006 80 mg Once Daily (Panel C)
Experimental
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Drug: MK-1006
MK-1006 120 mg Once Daily (Panel D)
Experimental
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Drug: MK-1006
MK-1006 20 mg Twice Daily (Panel E)
Experimental
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MK-1006
Drug
MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.
MK-1006 120 mg Once Daily (Panel D)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs) On Study
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
From Day 1 through the end of poststudy period (up to Day 25)
Number of Participants Who Discontinued Treatment Due to an AE
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
From Day 1 through the end of poststudy period (up to Day 25)
Secondary Outcomes
Measure
Description
Time Frame
Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit
Participant has been diagnosed with Type 2 Diabetes that is being treated either by diet and exercise alone or by single or combination oral anti-hyperglycemic medications
Participant is willing to follow a diet containing approximately 50% carbohydrates, 20% protein, and 30% fat during the study
Participant is a nonsmoker and has not used nicotine containing products for ~ 6 months before start of study
Exclusion Criteria:
Participant must not be treated with three or more oral anti-hyperglycemic medications, insulin, or PPAR-gamma agonists
Participant has a history of stroke, chronic seizures, or a major neurological disorder
Participant has had an eye infection or other inflammatory eye condition within 2 weeks of first dose of study drug
Participant has glaucoma or is blind
Participant has a condition known to be related to cataract development
Participant has had or will have incisional eye surgery within 6 months before screening or has had laser surgery (other than Lasik) within 3 months of screening
Participant has a history of type 1 diabetes or ketoacidosis
Participant cannot stop taking certain current medications during the study
Participant consumes greater than 3 alcoholic beverages per day
Participant consumes more than 6 servings of caffeinated beverages per day (1 serving is ~ 120 mg caffeine)
Participant has a history of significant multiple or severe allergies or has had a reaction to or is intolerant of prescription/non-prescription drugs or food
Participant uses recreational drugs or has had a history of drug abuse within 6 months of start of study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Monitor
Merck Sharp & Dohme LLC
Study Director
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
FG001
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG002
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG003
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG004
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG005
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG006
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
FG007
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
FG008
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
FG009
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0067 subjects
FG00720 subjects
FG00820 subjects
FG00929 subjects
COMPLETED
FG0006 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
All Treated Participants
After a 2-week run-in/wash-off period, participants received doses of MK-1006 or matching placebo over a multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Number of Participants Experiencing Adverse Events (AEs) On Study
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug
Posted
Number
participants
From Day 1 through the end of poststudy period (up to Day 25)
ID
Title
Description
OG000
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
Adverse Events Module
Frequency Threshold
5.0
Time Frame
Not provided
Description
Not provided
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
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA 15.0
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 15.0
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: MK-1006
MK-1006 30 mg Twice Daily (Panel F)
Experimental
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Drug: MK-1006
MK-1006 50 mg Twice Daily (Panel G)
Experimental
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
Drug: MK-1006
MK-1006 120 mg Once Daily Outpatient (Panel H)
Experimental
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
Drug: MK-1006
MK-1006 50 mg Twice Daily Outpatient (Panel I)
Experimental
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
Drug: MK-1006
Placebo
Placebo Comparator
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Drug: Comparator: Placebo comparator
MK-1006 120 mg Once Daily Outpatient (Panel H)
MK-1006 20 mg Once Daily (Panel A)
MK-1006 20 mg Twice Daily (Panel E)
MK-1006 30 mg Twice Daily (Panel F)
MK-1006 40 mg Once Daily (Panel B)
MK-1006 50 mg Twice Daily (Panel G)
MK-1006 50 mg Twice Daily Outpatient (Panel I)
MK-1006 80 mg Once Daily (Panel C)
Comparator: Placebo comparator
Drug
Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.
Placebo
Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)
6 subjects
FG0056 subjects
FG0066 subjects
FG00719 subjects
FG00818 subjects
FG00928 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
FG0091 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
Laboratory Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
112
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00053.1± 7.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00051
Male
BG00061
OG001
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG002
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG003
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG004
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG005
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG006
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG007
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
OG008
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
OG009
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0067
OG00720
OG00820
OG00929
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0024
OG0035
OG0044
OG0054
OG0066
OG00715
OG00816
OG00922
Secondary
Least Squares Mean Change From Baseline in 24-Hour Weighted Mean Glucose (WMG)
Plasma glucose concentration was determined using a glucometer and measured before drug was given to establish a baseline fasting plasma glucose concentration. Plasma glucose concentrations were then measured every ~30 minutes over a 24 hour period after the Day 1 dose (First Dosing Day) and after the Day 10 dose (Last Dosing Day) to obtain a weighted mean average value for Day 1 and for Day 10. Results were expressed as the change from baseline to the Day 1 weighted average (First Dosing Day), and as the change from baseline to the Day 10 weighted average (Last Dosing Day).
Per-Protocol Population; subset of participants who complied with the protocol sufficiently in terms of considerations as exposure to treatment, availability of measurements and absence of major protocol violations.
Posted
Least Squares Mean
Standard Deviation
mg/dL
Day -1 (pre-dose baseline), Day 1 (First Dosing Day), Day 10 (Last Dosing Day)
ID
Title
Description
OG000
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
OG001
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG002
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG003
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG004
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG005
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG006
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG007
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
First Dosing Day
Title
Measurements
OG000-5.3± 11.3
OG001-19.3± 15.1
OG002-43.8± 10.1
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
OG003
OG007
Mixed Effect Model
0.015
LS Mean Difference on Last Dosing Day
37.63
2-Sided
95
12.58
62.68
No
Superiority or Other
OG006
OG007
Mixed Effect Model
<0.001
Primary
Number of Participants Who Discontinued Treatment Due to an AE
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the study treatment, was also an adverse event.
All Participants as Treated (APaT); All participants who received at least one dose of the investigational drug
Posted
Number
participants
From Day 1 through the end of poststudy period (up to Day 25)
ID
Title
Description
OG000
MK-1006 20 mg Once Daily (Panel A)
After a 2-week run-in/wash-off period, participants received single daily doses (q.d.) of 20 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the Clinical Research Unit (CRU).
OG001
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG002
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG003
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG004
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG005
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG006
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
OG007
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
OG008
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
OG009
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
6
1
6
EG001
MK-1006 40 mg Once Daily (Panel B)
After a 2-week run-in/wash-off period, participants received single daily doses of 40 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
6
1
6
EG002
MK-1006 80 mg Once Daily (Panel C)
After a 2-week run-in/wash-off period, participants received single daily doses of 80 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
6
4
6
EG003
MK-1006 120 mg Once Daily (Panel D)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
6
5
6
EG004
MK-1006 20 mg Twice Daily (Panel E)
After a 2-week run-in/wash-off period, participants received twice-daily doses (b.i.d.) of 120 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
6
2
6
EG005
MK-1006 30 mg Twice Daily (Panel F)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 30 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
6
4
6
EG006
MK-1006 50 mg Twice Daily (Panel G)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 10-day multiple-dosing period while remaining domiciled in the CRU.
0
7
6
7
EG007
MK-1006 120 mg Once Daily Outpatient (Panel H)
After a 2-week run-in/wash-off period, participants received single daily doses of 120 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
1
20
15
20
EG008
MK-1006 50 mg Twice Daily Outpatient (Panel I)
After a 2-week run-in/wash-off period, participants received twice-daily doses of 50 mg MK-1006 over a 7-day multiple-dosing period while remaining domiciled in the CRU. Participants were then discharged from the CRU and continued daily dosing of MK-1006 for an additional 21 days as outpatients.
0
20
16
20
EG009
Placebo
After a 2-week run-in/wash-off period, participants received dose-matched placebo to MK-1006 over a multiple-dosing period while remaining domiciled in the CRU.
1
29
22
29
EG000
0 events
0 affected
6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0071 affected20 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected29 at risk
Atrial Fibrillation
Cardiac disorders
MedDRA 15.0
EG0000 events0 affected6 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected7 at risk
EG0070 events0 affected20 at risk
EG0080 events0 affected20 at risk
EG0091 affected29 at risk
EG000
0 affected
6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Palpitations
Cardiac disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Asthenopia
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Blepharospasm
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Conjunctival Haemorrhage
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Diabetic Retinopathy
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Dry Eye
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Eye Irritation
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Eye Pain
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Lenticular Opacities
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Vision Blurred
Eye disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0073 affected20 at risk
EG0080 affected20 at risk
EG0092 affected29 at risk
Abdominal Distension
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Constipation
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0064 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0091 affected29 at risk
Diarrhea
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Dry Mouth
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Flatulence
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0093 affected29 at risk
Gastroesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Glossodynia
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Mouth Ulceration
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Nausea
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0083 affected20 at risk
EG0090 affected29 at risk
Paraesthesia Oral
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Retching
Gastrointestinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Application Site Irritation
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0091 affected29 at risk
Chest Discomfort
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Chest Pain
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Chills
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Fatigue
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Malaise
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Oedema Peripheral
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Pain
General disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Liver Disorder
Hepatobiliary disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Diverticulitis
Infections and infestations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Viral Infection
Infections and infestations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Alanine Aminotransferase Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Aspartate Aminotransferase Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Blood Glucose Decreased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0061 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Blood Glucose Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Blood Triglycerides Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Electrocardiogram QT Prolonged
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Gamma-Glutamyltransferase Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Haematocrit Decreased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Haemoglobin Decreased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
White Blood Cell Count Increased
Investigations
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0031 affected6 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0062 affected7 at risk
EG0075 affected20 at risk
EG0084 affected20 at risk
EG0091 affected29 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0071 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Dizziness
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0041 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0072 affected20 at risk
EG0082 affected20 at risk
EG0094 affected29 at risk
Dysgeusia
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0051 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Headache
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG0033 affected6 at risk
EG0042 affected6 at risk
EG0050 affected6 at risk
EG0066 affected7 at risk
EG0073 affected20 at risk
EG0085 affected20 at risk
EG0094 affected29 at risk
Presyncope
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Sinus Headache
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Somnolence
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0072 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Tremor
Nervous system disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0083 affected20 at risk
EG0090 affected29 at risk
Pollakiuria
Renal and urinary disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Polyuria
Renal and urinary disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0072 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0092 affected29 at risk
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Paranasal Sinus Hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Sinus Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0090 affected29 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0093 affected29 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Pruritus Generalised
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Skin Irritation
Skin and subcutaneous tissue disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0031 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0081 affected20 at risk
EG0091 affected29 at risk
Flushing
Vascular disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0091 affected29 at risk
Hot Flush
Vascular disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0071 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Pallor
Vascular disorders
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0060 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
Peripheral Coldness
Surgical and medical procedures
MedDRA 15.0
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected6 at risk
EG0040 affected6 at risk
EG0050 affected6 at risk
EG0061 affected7 at risk
EG0070 affected20 at risk
EG0080 affected20 at risk
EG0090 affected29 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.