A Study to Evaluate the Change in Weight After 24 Weeks T... | NCT03100058 | Trialant
NCT03100058
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Feb 6, 2020Actual
Enrollment
460Actual
Phase
Phase 2
Conditions
Obesity
Overweight
Interventions
LIK066
Placebo
Countries
United States
Austria
Canada
Czechia
Hungary
Slovakia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03100058
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLIK066B2201
Secondary IDs
ID
Type
Description
Link
2016-002868-14
EudraCT Number
Brief Title
A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Official Title
A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jan 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
May 6, 2017Actual
Primary Completion Date
Mar 2, 2018Actual
Completion Date
Aug 2, 2018Actual
First Submitted Date
Mar 3, 2017
First Submission Date that Met QC Criteria
Mar 28, 2017
First Posted Date
Apr 4, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jul 30, 2019
Results First Submitted that Met QC Criteria
Jan 27, 2020
Results First Posted Date
Feb 6, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 16, 2019
Certification/Extension First Submitted that Passed QC Review
Jan 16, 2019
Certification/Extension First Posted Date
Jan 17, 2019Actual
Last Update Submitted Date
Jan 27, 2020
Last Update Posted Date
Feb 6, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.
Detailed Description
Not provided
Conditions Module
Conditions
Obesity
Overweight
Keywords
Obesity
Overweight
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
460Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LIK066 2.5mg qd (Epoch 3)
Experimental
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.
Drug: LIK066
Placebo (Epoch 3)
Placebo Comparator
Matching placebo tablets for 24 weeks
Drug: Placebo
LIK066 10mg qd (Epoch 3)
Experimental
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 50mg qd (Epoch 3)
Experimental
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 150mg qd (Epoch 3)
Experimental
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 2.5mg bid (Epoch 3)
Experimental
LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LIK066
Drug
LIK066 will be supplied in different doses as tablets to be taken orally.
LIK066 10mg qd (Epoch 3)
LIK066 150mg qd (Epoch 3)
LIK066 2.5mg bid (Epoch 3)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Body Weight at 24 Weeks
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Baseline, Week 24 (Epoch 3)
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Baseline, Week 24
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
informed consent
(BMI>=30) or (BMI>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)
willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)
Exclusion Criteria:
Hypersensitivity to any of the study medications
Pregnancy or lactating women
History of malignancies
Use of pharmacologically active weight loss products
Bariatric surgery
Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.
HbA1c >10% at the screening visit.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 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
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Novartis Investigative Site
Anniston
Alabama
36207
United States
Novartis Investigative Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Recruitment Details
Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
FG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
Periods
Title
Milestones
Reasons Not Completed
Epoch 3 (24 Weeks of Treatment)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 19, 2017
Jul 30, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug: LIK066
LIK066 5mg bid (Epoch 3)
Experimental
LIK066 5mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 25mg bid (Epoch 3)
Experimental
LIK066 25mg bid (once daily) dosing frequency for 24 weeks
Drug: LIK066
LIK066 50mg bid (Epoch 3)
Experimental
LIK066 50mg bid dosing frequency for 24 weeks
Drug: LIK066
LIK066 qd/LIK066 25mg qd (Epoch 4)
Experimental
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
LIK066 bid/LIK066 35mg qd (Epoch 4)
Experimental
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
Placebo/LIK066 25mg qd (Epoch 4)
Experimental
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: LIK066
Placebo/Placebo (Epoch 4)
Placebo Comparator
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Drug: Placebo
LIK066 2.5mg qd (Epoch 3)
LIK066 25mg bid (Epoch 3)
LIK066 50mg bid (Epoch 3)
LIK066 50mg qd (Epoch 3)
LIK066 5mg bid (Epoch 3)
LIK066 bid/LIK066 35mg qd (Epoch 4)
LIK066 qd/LIK066 25mg qd (Epoch 4)
Placebo/LIK066 25mg qd (Epoch 4)
Placebo
Drug
Placebo
Placebo (Epoch 3)
Placebo/Placebo (Epoch 4)
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Baseline, Week 24
Percentage Change From Baseline on Waist Circumference
Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Between Week 24 and Week 48 (Epoch 4)
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Baseline, Week 24
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Baseline, Week 24, Week 48
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Week 24, Week 48
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
Week 24, Week 48
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
Observe maximum plasma concentration following administration of LIK066 (Cmax)
Summary at Week 24 from qd or bid regimens
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
Time to reach the maximum concentration after administration of LIK066 (Tmax)
Summary at Week 24 for qd or bid regimens
Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Summary at Week 24 from qd or bid regimens (0-6h)
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
Last non-zero concentration area under the curve (AUClast)
Summary at Week 24 from qd or bid regimens
Jasper
Alabama
35501
United States
Novartis Investigative Site
Beverly Hills
California
90211
United States
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Carmichael
California
95608
United States
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Concord
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94520
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Los Angeles
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91325
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95661
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80246
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Bradenton
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34209
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33312
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33401
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Athens
Georgia
30606
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Augusta
Georgia
30909
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Honolulu
Hawaii
96814
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Gurnee
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60031
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70006
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70119
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Baltimore
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City of Saint Peters
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St Louis
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United States
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Missoula
Montana
59808
United States
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Omaha
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68134
United States
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New York
New York
10016
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New York
New York
10021
United States
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The Bronx
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10455
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Hickory
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28601
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Lansdale
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19446
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15212
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Moncks Corner
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29464
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Summerville
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29485
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77081
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84010
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23606
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23235
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98057
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98405
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53144
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Graz
8036
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Vienna
1010
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Vienna
1030
Austria
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Toronto
Ontario
M4G 3E8
Canada
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Toronto
Ontario
M9W 4L6
Canada
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Gatineau
Quebec
J8Y 6S8
Canada
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Lévis
Quebec
G6W 5M6
Canada
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Prague
Czech Republic
128 08
Czechia
Novartis Investigative Site
České Budějovice
370 01
Czechia
Novartis Investigative Site
Olomouc Lazce
77900
Czechia
Novartis Investigative Site
Prague
116 94
Czechia
Novartis Investigative Site
Prague
13000
Czechia
Novartis Investigative Site
Slaný
274 01
Czechia
Novartis Investigative Site
Csongrád
6640
Hungary
Novartis Investigative Site
Nyíregyháza
4400
Hungary
Novartis Investigative Site
Szentes
6600
Hungary
Novartis Investigative Site
Bratislava
85101
Slovakia
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Košice
040 01
Slovakia
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Sereď
92601
Slovakia
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Basingstoke
RG24 9DT
United Kingdom
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Blackburn
BB2 1AX
United Kingdom
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Exeter
EX2 5DW
United Kingdom
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Rotherham
S65 1DA
United Kingdom
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Stevenage
SG1 4AB
United Kingdom
FG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
FG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
FG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
FG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
FG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
FG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
FG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
FG009
LIK066 qd/LIK066 25 mg qd (Epoch 4)
LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd
FG010
LIK066 Bid/LIK066 35 mg qd (Epoch 4)
LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd
FG011
Placebo/LIK066 25 mg qd (Epoch 4)
Matching placebo tablets for 24 weeks
FG012
Placebo qd (Epoch 4)
Placebo patients who entered Epoch 4 and received matching Placebo tablets qd
FG00038 subjects
FG00138 subjects
FG00238 subjects
FG00377 subjects
FG00438 subjects
FG00539 subjects
FG00638 subjects
FG00776 subjects
FG00878 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00035 subjects
FG00131 subjects
FG00229 subjects
FG00363 subjects
FG00436 subjects
FG00537 subjects
FG00630 subjects
FG00760 subjects
FG00873 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0029 subjects
FG00314 subjects
FG0042 subjects
FG0052 subjects
FG0068 subjects
FG00716 subjects
FG0085 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0038 subjects
FG0041 subjects
FG0050 subjects
FG0063 subjects
FG00711 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0023 subjects
FG0034 subjects
FG004
Non-compliance with study treatment
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Epoch 4 (Last 24 Weeks of the Study)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG009158 subjects
FG010163 subjects
FG01139 subjects
FG01234 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
BG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
BG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
BG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
BG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
BG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
BG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
BG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
BG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00038
BG00138
BG00238
BG00377
BG00438
BG00539
BG00638
BG00776
BG00878
BG009460
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
BG00051.3± 12.20
BG00153.2± 10.08
BG00252.9± 13.60
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00023
BG00127
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0010
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
Percent Change From Baseline in Body Weight at 24 Weeks
Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment
Full Analysis Set
Posted
Mean
95% Confidence Interval
Percent change
Baseline, Week 24 (Epoch 3)
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG003
Title
Denominators
Categories
Title
Measurements
OG000-1.24(-2.50 to -0.45)
OG001-2.04(-3.36 to -0.88)
OG002-3.52(-4.62 to -1.87)
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
OG008
ANCOVA
<0.0001
Mean Difference (Net)
-1.73
2-Sided
95
-3.17
-0.29
Other
Dose finding study
OG001
OG008
ANCOVA
<0.0001
Secondary
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline
Full Analysis Set
Posted
Number
Percentage
Baseline, Week 24
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups
Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)
Full Analysis Set
Posted
Number
Percentage
Baseline, Week 24
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Percentage Change From Baseline on Waist Circumference
Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)
At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)
Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)
Full Analysis Set
Posted
Mean
95% Confidence Interval
Percentage
Between Week 24 and Week 48 (Epoch 4)
ID
Title
Description
OG000
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG001
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG002
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Secondary
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.
Full Analysis Set
Posted
Mean
Standard Deviation
mmol/24hr
Baseline, Week 24
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
Secondary
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion
Evaluation of 24-hour urinary calcium after 48 weeks of treatment
Full Analysis Set
Posted
Mean
Standard Deviation
mmol/24hr
Baseline, Week 24, Week 48
ID
Title
Description
OG000
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG001
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG002
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Secondary
Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment
Full Analysis Set
Posted
Mean
Standard Deviation
mmol/24hr
Week 24, Week 48
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
Secondary
Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion
Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment
Full Analysis Set
Posted
Mean
Standard Deviation
mmol/24hr
Week 24, Week 48
ID
Title
Description
OG000
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG001
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG002
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Secondary
Change From Baseline in Fasting Lipid Profile (Lipoproteins)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Full Analysis Set
Posted
Mean
95% Confidence Interval
g/L
Baseline, Week 24, Week 24 to Week 48 (Epoch 4)
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Change From Baseline in High Sensitive C-reactive Protein (hsCRP)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Full Analysis Set
Posted
Geometric Mean
95% Confidence Interval
mg/L
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)
Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48
Full Analysis Set
Posted
Mean
95% Confidence Interval
mmol/L
Baseline to Week 24, Week 24 to Week 48 (Epoch 4)
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)
Observe maximum plasma concentration following administration of LIK066 (Cmax)
Full Analysis Set
Posted
Mean
Standard Deviation
ng/mL
Summary at Week 24 from qd or bid regimens
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)
Time to reach the maximum concentration after administration of LIK066 (Tmax)
Full Analysis Set
Posted
Median
Full Range
hour
Summary at Week 24 for qd or bid regimens
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
Secondary
Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)
Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)
Full Analysis Population
Posted
Mean
Standard Deviation
hr*ng/mL
Summary at Week 24 from qd or bid regimens (0-6h)
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
Secondary
Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)
Last non-zero concentration area under the curve (AUClast)
Full Analysis Set
Posted
Mean
Standard Deviation
hr*ng/mL
Summary at Week 24 from qd or bid regimens
ID
Title
Description
OG000
LIK066 2.5mg qd (Epoch 3)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks
OG001
LIK066 10mg qd (Epoch 3)
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
OG002
LIK066 50mg qd (Epoch 3)
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
OG003
LIK066 150mg qd (Epoch 3)
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
OG004
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
Time Frame
Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.
Description
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
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
LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)
LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4)
0
38
3
38
33
38
EG001
LIK066 10 mg qd/25 mg qd
LIK066 10mg qd (once daily) dosing frequency for 24 weeks
1
38
3
38
24
38
EG002
LIK066 50 mg qd/25 mg qd
LIK066 50mg qd (once daily) dosing frequency for 24 weeks
0
38
1
38
24
38
EG003
LIK066 150 mg qd/25 mg qd
LIK066 150mg qd (once daily) dosing frequency for 24 weeks
0
77
3
77
55
77
EG004
LIK066 2.5 mg Bid/35 mg qd
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
1
38
5
38
31
38
EG005
LIK066 5 mg Bid/35 mg qd
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
0
39
2
39
32
39
EG006
LIK066 25 mg Bid/35 mg qd
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
0
38
2
38
26
38
EG007
LIK066 50 mg Bid/35 mg qd
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
0
76
1
76
47
76
EG008
Placebo/LIK066 25 mg qd (Epoch 4)
Matching placebo tablets for 24 weeks
0
40
1
40
32
40
EG009
Placebo/Placebo
Matching placebo tablets
0
38
4
38
32
38
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG0030 affected77 at risk
EG0040 affected38 at risk
EG0050 affected39 at risk
EG0060 affected38 at risk
EG0070 affected76 at risk
EG0080 affected40 at risk
EG0090 affected38 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Obstructive pancreatitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Leiomyosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dyspareunia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Circulatory collapse
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG0030 affected77 at risk
EG0041 affected38 at risk
EG0050 affected39 at risk
EG0060 affected38 at risk
EG0070 affected76 at risk
EG0081 affected40 at risk
EG0090 affected38 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Polycythaemia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Microvascular coronary artery disease
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Porokeratosis
Congenital, familial and genetic disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Type IIa hyperlipidaemia
Congenital, familial and genetic disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Inner ear disorder
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Tympanic membrane perforation
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Blepharospasm
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cataract
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dry eye
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eye pruritus
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Myopic chorioretinal degeneration
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Visual impairment
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0023 affected38 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0012 affected38 at risk
EG0024 affected38 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0022 affected38 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0013 affected38 at risk
EG0024 affected38 at risk
EG003
Bowel movement irregularity
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Breath odour
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0006 affected38 at risk
EG0017 affected38 at risk
EG0026 affected38 at risk
EG003
Defaecation urgency
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0024 affected38 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG00014 affected38 at risk
EG0017 affected38 at risk
EG00215 affected38 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Dyschezia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0011 affected38 at risk
EG0021 affected38 at risk
EG003
Eosinophilic oesophagitis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0022 affected38 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0012 affected38 at risk
EG0022 affected38 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0007 affected38 at risk
EG0019 affected38 at risk
EG0029 affected38 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0012 affected38 at risk
EG0024 affected38 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0024 affected38 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Glossodynia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0013 affected38 at risk
EG0023 affected38 at risk
EG003
Splenic artery aneurysm
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Tooth disorder
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Asthenia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Chest discomfort
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Chest pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Chills
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Fatigue
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Feeling cold
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hunger
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Influenza like illness
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Oedema peripheral
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Pain
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Peripheral swelling
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Pyrexia
General disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Thirst
General disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Biliary dyskinesia
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Bacterial vulvovaginitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Balanitis candida
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0004 affected38 at risk
EG0010 affected38 at risk
EG0022 affected38 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cystitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Cystitis bacterial
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ear infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eye infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Folliculitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Fungal infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gastrointestinal viral infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Genital candidiasis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Genital herpes zoster
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Influenza
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0004 affected38 at risk
EG0012 affected38 at risk
EG0023 affected38 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0012 affected38 at risk
EG0020 affected38 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Otitis externa
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Otitis externa fungal
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Otitis media
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Paronychia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sinobronchitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0023 affected38 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Tooth infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Tracheitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0013 affected38 at risk
EG0023 affected38 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0011 affected38 at risk
EG0023 affected38 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vestibular neuronitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Viral infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Vulvitis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Wound infection
Infections and infestations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0023 affected38 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0012 affected38 at risk
EG0021 affected38 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Post procedural discomfort
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Amylase decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Apolipoprotein A-I decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood albumin increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood glucose increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood potassium decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Blood potassium increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Cardiac murmur
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Creatinine urine increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Electrocardiogram change
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Glomerular filtration rate increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Glycosylated haemoglobin increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Haematocrit increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Haemoglobin increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Haemoglobin urine present
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Heart rate decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Heart rate irregular
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
High density lipoprotein decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Lipase abnormal
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Lipase increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Liver function test increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Liver scan abnormal
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Protein urine present
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Urine albumin/creatinine ratio increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0023 affected38 at risk
EG003
Urine leukocyte esterase
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Urine leukocyte esterase positive
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Weight increased
Investigations
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Appetite disorder
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0021 affected38 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0022 affected38 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0012 affected38 at risk
EG0020 affected38 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Increased appetite
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Ketosis
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0014 affected38 at risk
EG0021 affected38 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dupuytren's contracture
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Extremity contracture
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0021 affected38 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0012 affected38 at risk
EG0020 affected38 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0003 affected38 at risk
EG0013 affected38 at risk
EG0021 affected38 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Scleroderma
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0022 affected38 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Benign neoplasm of conjunctiva
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Facial paralysis
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Headache
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0002 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Migraine
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Nerve compression
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0012 affected38 at risk
EG0020 affected38 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Syncope
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Tremor
Nervous system disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Unintended pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Device dislocation
Product Issues
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0022 affected38 at risk
EG003
Binge drinking
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Depression
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0012 affected38 at risk
EG0021 affected38 at risk
EG003
Grief reaction
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0022 affected38 at risk
EG003
Organic brain syndrome
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Stress
Psychiatric disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Microalbuminuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0022 affected38 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Renal cyst
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Atrophic vulvovaginitis
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Breast haematoma
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Epididymal cyst
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Vulval disorder
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hydrothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Lichen sclerosus
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0012 affected38 at risk
EG0020 affected38 at risk
EG003
Pustular psoriasis
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0021 affected38 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hot flush
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Hypertension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0011 affected38 at risk
EG0020 affected38 at risk
EG003
Hypotension
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0001 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA (21.0)
Systematic Assessment
EG0000 affected38 at risk
EG0010 affected38 at risk
EG0020 affected38 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00637
OG00775
OG00878
Title
Denominators
Categories
>=5%
Title
Measurements
OG00026.3
OG00115.8
OG00234.2
OG00342.9
OG00415.8
OG00520.5
OG00637.8
OG00745.3
OG00812.8
>=10%
Title
Measurements
OG0005.3
OG0015.3
OG0025.3
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
OG008
>=5%
ANCOVA
0.099
Odds Ratio (OR)
2.38
2-Sided
95
0.85
6.67
Other
Dose finding study
OG001
OG008
>=5%
ANCOVA
0.779
Odds Ratio, log
1.18
2-Sided
95
0.36
3.84
Other
Dose finding study
OG002
OG008
>=5%
ANCOVA
0.011
Odds Ratio (OR)
3.69
2-Sided
95
1.35
10.11
Other
Dose finding study
OG003
OG008
>=5%
ANCOVA
<.001
Odds Ratio (OR)
5.57
2-Sided
95
2.41
12.88
Other
Dose finding study
OG004
OG008
>=5%
ANCOVA
0.812
Odds Ratio (OR)
1.15
2-Sided
95
0.36
3.74
Other
Dose finding study
OG005
OG008
>=5%
ANCOVA
0.229
Odds Ratio (OR)
1.94
2-Sided
95
0.66
5.69
Other
Dose finding study
OG006
OG008
>=5%
ANCOVA
0.004
Odds Ratio (OR)
4.29
2-Sided
95
1.61
11.46
Other
Dose finding study
OG007
OG008
>=5%
ANCOVA
<.001
Odds Ratio (OR)
6.37
2-Sided
95
2.72
14.93
Other
Dose finding study
OG000
OG008
>=10%
ANCOVA
0.943
Odds Ratio (OR)
1.09
2-Sided
95
0.10
12.41
Other
Dose finding study
OG001
OG008
>=10%
ANCOVA
0.465
Odds Ratio (OR)
2.11
2-Sided
95
0.28
15.77
Other
Dose finding study
OG002
OG008
>=10%
ANCOVA
0.696
Odds Ratio (OR)
1.60
2-Sided
95
0.15
17.15
Other
Dose finding study
OG003
OG008
>=10%
ANCOVA
0.389
Odds Ratio (OR)
2.14
2-Sided
95
0.38
12.10
Other
Dose finding study
OG004
OG008
>=10%
ANCOVA
0.976
Odds Ratio (OR)
1.04
2-Sided
95
0.09
11.87
Other
Dose finding study
OG005
OG008
>=10%
ANCOVA
0.986
Odds Ratio (OR)
1.02
2-Sided
95
0.09
11.70
Other
Dose finding study
OG006
OG008
>=10%
ANCOVA
0.181
Odds Ratio (OR)
3.51
2-Sided
95
0.56
22.18
Other
Dose finding study
OG007
OG008
>=10%
ANCOVA
0.100
Odds Ratio (OR)
3.97
2-Sided
95
0.77
20.54
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00637
OG00775
OG00878
Title
Denominators
Categories
Dysglycemic (>=5%)
ParticipantsOG00016
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG00331
ParticipantsOG00415
ParticipantsOG00516
ParticipantsOG00615
ParticipantsOG00731
ParticipantsOG00831
Title
Measurements
OG00031.3
OG00125.0
OG00240.0
OG003
Normoglycemic (>=5%)
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00319
Type 2 Diabetes Mellitus (T2DM) (>=5%)
ParticipantsOG00013
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00327
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
OG008
>=5% (Dysglycemic)
ANCOVA
0.048
Odds Ratio (OR)
6.29
2-Sided
95
1.02
38.76
Other
Dose finding study
OG001
OG008
>=5% (Dsyglycemic)
ANCOVA
0.171
Odds Ratio, log
3.94
2-Sided
95
0.55
28.03
Other
Dose finding study
OG002
OG008
>=5% (Dysglycemic)
ANCOVA
0.041
Odds Ratio (OR)
7.17
2-Sided
95
1.09
47.27
Other
Dose finding study
OG003
OG008
>=5% (Dysglycemic)
ANCOVA
0.003
Odds Ratio (OR)
11.89
2-Sided
95
2.32
60.93
Other
Dose finding study
OG004
OG008
>=5% (Dysglycemic)
ANCOVA
0.976
Odds Ratio (OR)
0.96
2-Sided
95
0.08
11.72
Other
Dose finding study
OG005
OG008
>=5% (Dysglycemic)
ANCOVA
0.022
Odds Ratio (OR)
8.78
2-Sided
95
1.37
56.44
Other
Dose finding study
OG006
OG008
>=5% (Dysglycemic)
ANCOVA
0.032
Odds Ratio (OR)
7.50
2-Sided
95
1.20
46.99
Other
Dose finding study
OG007
OG008
>=5% (Dysglycemic)
ANCOVA
0.005
Odds Ratio (OR)
11.28
2-Sided
95
2.11
60.46
Other
Dose finding study
OG000
OG008
>=5% (Normoglycemic)
ANCOVA
0.227
Odds Ratio (OR)
3.21
2-Sided
95
0.48
21.28
Other
Dose finding study
OG001
OG008
>=5% (Normoglycemic)
ANCOVA
0.763
Odds Ratio (OR)
0.69
2-Sided
95
0.06
7.85
Other
Dose finding study
OG002
OG008
>=5% (Normoglycemic)
ANCOVA
0.095
Odds Ratio (OR)
4.68
2-Sided
95
0.76
28.70
Other
Dose finding study
OG003
OG008
>=5% (Normoglycemic)
ANCOVA
0.033
Odds Ratio (OR)
5.33
2-Sided
95
1.14
24.83
Other
Dose finding study
OG004
OG008
>=5% (Normoglycemic)
ANCOVA
0.788
Odds Ratio (OR)
0.72
2-Sided
95
0.06
8.10
Other
Dose finding study
OG005
OG008
>=5% (Normoglycemic)
ANCOVA
0.751
Odds Ratio (OR)
0.68
2-Sided
95
0.06
7.62
Other
Dose finding study
OG006
OG008
>=5% (Normoglycemic)
ANCOVA
0.027
Odds Ratio (OR)
8.05
2-Sided
95
1.27
51.09
Other
Dose finding study
OG007
OG008
>=5% (Normoglycemic)
ANCOVA
0.023
Odds Ratio (OR)
6.64
2-Sided
95
1.30
34.00
Other
Dose finding study
OG000
OG008
>=5% (T2DM)
ANCOVA
0.528
Odds Ratio (OR)
0.48
2-Sided
95
0.05
4.78
Other
Dose finding study
OG001
OG008
>=5% (T2DM)
ANCOVA
0.958
Odds Ratio (OR)
1.05
2-Sided
95
0.17
6.68
Other
Dose finding study
OG002
OG008
>=5% (T2DM)
ANCOVA
0.546
Odds Ratio (OR)
1.70
2-Sided
95
0.30
9.49
Other
Dose finding study
OG003
OG008
>=5% (T2DM)
ANCOVA
0.098
Odds Ratio (OR)
3.09
2-Sided
95
0.81
11.75
Other
Dose finding test
OG004
OG008
>=5% (T2DM)
ANCOVA
0.563
Odds Ratio (OR)
1.64
2-Sided
95
0.31
8.70
Other
Dose finding study
OG005
OG008
>=5% (T2DM)
ANCOVA
0.610
Odds Ratio (OR)
0.55
2-Sided
95
0.06
5.38
Other
Dose finding study
OG006
OG008
>=5% (T2DM)
ANCOVA
0.528
Odds Ratio (OR)
1.71
2-Sided
95
0.32
9.16
Other
Dose finding study
OG007
OG008
>=5% (T2DM)
ANCOVA
0.023
Odds Ratio (OR)
4.55
2-Sided
95
1.23
16.90
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Title
Measurements
OG000-2.1(-3.87 to -0.31)
OG001-2.7(-4.55 to -0.92)
OG002-3.7(-5.55 to -1.82)
OG003-5.6(-6.84 to -4.35)
OG004-2.7(-4.47 to -0.91)
OG005-4.3(-6.07 to -2.57)
OG006-4.8(-6.61 to -2.98)
OG007-4.6(-5.89 to -3.31)
OG008-1.3(-2.54 to -0.05)
OG009-0.4(-1.25 to 0.36)
OG010-0.7(-1.53 to 0.10)
OG011-2.1(-3.73 to -0.38)
OG0120.4(-1.37 to 2.20)
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
OG008
ANCOVA
0.470
Median Difference (Net)
-0.8
2-Sided
95
-2.96
1.37
Other
Dose finding study
OG001
OG008
ANCOVA
0.199
Median Difference (Net)
-1.4
2-Sided
95
-3.64
0.76
Other
Dose finding study
OG003
OG008
ANCOVA
<0.001
Median Difference (Net)
-1.4
2-Sided
95
-3.64
0.76
Other
Dose finding study
OG004
OG008
ANCOVA
0.206
Mean Difference (Net)
-1.4
2-Sided
95
-3.56
0.77
Other
Dose finding study
OG005
OG008
ANCOVA
0.006
Median Difference (Net)
-3.0
2-Sided
95
-5.18
-0.88
Other
Dose finding study
OG006
OG008
ANCOVA
0.002
Median Difference (Net)
-3.5
2-Sided
95
-5.70
-1.30
Other
Dose finding study
OG007
OG008
ANCOVA
<0.001
Mean Difference (Net)
-3.3
2-Sided
95
-5.10
-1.51
Other
Dose finding study
OG009
OG012
ANCOVA
0.391
Median Difference (Net)
-0.9
2-Sided
95
-2.82
1.10
Other
Dose finding study
OG010
OG012
ANCOVA
0.259
Median Difference (Net)
-2.5
2-Sided
95
-3.10
0.84
Other
Dose finding study
OG011
OG012
ANCOVA
0.048
Mean Difference (Net)
-2.5
2-Sided
95
-4.91
-0.02
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Title
Measurements
OG0001.9(0.55 to 3.19)
OG001-0.1(-1.46 to 1.27)
OG002-1.2(-2.60 to 0.26)
OG003-0.8(-1.70 to 0.16)
OG004-0.5(-1.80 to 0.86)
OG005-1.1(-2.37 to 0.27)
OG006-0.9(-2.28 to 0.46)
OG007-1.0(-1.96 to -0.13)
OG0080.9(-0.06 to 1.81)
OG009-0.1(-0.64 to 0.35)
OG010-0.3(-0.79 to 0.22)
OG011-0.1(-1.14 to 0.84)
OG0120.6(-0.54 to 1.73)
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
OG008
ANCOVA
0.225
Mean Difference (Net)
1.0
2-Sided
95
-0.62
2.61
Other
Dose finding study
OG001
OG008
ANCOVA
0.247
Mean Difference (Net)
-1.0
2-Sided
95
-2.62
0.68
Other
Dose finding study
OG002
OG008
ANCOVA
0.019
Median Difference (Net)
-2.0
2-Sided
95
-3.75
-0.34
Other
Dose finding study
OG003
OG008
ANCOVA
0.015
Mean Difference (Net)
-1.6
2-Sided
95
-2.96
-0.33
Other
Dose finding study
OG004
OG008
ANCOVA
0.106
Mean Difference (Net)
-1.3
2-Sided
95
-2.97
0.29
Other
Dose finding study
OG005
OG008
ANCOVA
0.020
Mean Difference (Net)
-1.9
2-Sided
95
-3.54
-0.31
Other
Dose finding study
OG006
OG008
ANCOVA
0.035
Mean Difference (Net)
-1.8
2-Sided
95
-3.44
-0.12
Other
Dose finding study
OG007
OG008
ANCOVA
0.004
Mean Difference (Net)
-1.9
2-Sided
95
-3.22
-0.61
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Title
Measurements
OG0000.1(-0.23 to 0.45)
OG001-0.5(-0.82 to -0.13)
OG002-0.9(-1.24 to -0.50)
OG003-0.7(-0.92 to -0.44)
OG004-0.3(-0.68 to 0.00)
OG005-0.5(-0.83 to -0.15)
OG006-0.6(-0.98 to -0.28)
OG007-0.6(-0.87 to -0.40)
OG008-0.3(-0.50 to -0.02)
OG0090.2(0.03 to 0.38)
OG0100.0(-0.13 to 0.22)
OG011-0.1(-0.49 to 0.24)
OG0120.3(-0.07 to 0.71)
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
OG008
ANCOVA
0.082
Mean Difference (Net)
0.4
2-Sided
95
-0.05
0.79
Other
Dose finding study
OG001
OG008
ANCOVA
0.319
Median Difference (Net)
-0.2
2-Sided
95
-0.63
0.21
Other
Dose finding study
OG002
OG008
ANCOVA
0.008
Mean Difference (Net)
-0.4
2-Sided
95
-1.05
-0.16
Other
Dose finding study
OG003
OG008
ANCOVA
0.015
Mean Difference (Net)
-0.4
2-Sided
95
-0.76
-0.08
Other
Dose finding study
OG004
OG008
ANCOVA
0.707
Mean Difference (Net)
-0.1
2-Sided
95
-0.50
0.34
Other
Dose finding study
OG005
OG008
ANCOVA
0.280
Mean Difference (Net)
-0.2
2-Sided
95
-0.65
0.19
Other
Dose finding study
OG006
OG008
ANCOVA
0.086
Mean Difference (Net)
-0.4
2-Sided
95
-0.80
0.05
Other
Dose finding study
OG007
OG008
ANCOVA
0.030
Mean Difference (Net)
-0.4
2-Sided
95
-0.72
-0.04
Other
Dose finding study
LIK066 2.5mg Bid (Epoch 3)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
systolic blood pressure (SBP)
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00238
ParticipantsOG00377
ParticipantsOG00438
ParticipantsOG00539
ParticipantsOG00637
ParticipantsOG00775
ParticipantsOG00878
ParticipantsOG00958
ParticipantsOG010162
ParticipantsOG01137
ParticipantsOG01234
Title
Measurements
OG000-1.2(-4.38 to 1.93)
OG001-1.5(-4.38 to 1.93)
OG002-4.9(-8.30 to -1.52)
OG003
diastolic blood pressure (DBP)
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00238
ParticipantsOG00377
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
OG008
SBP
ANCOVA
0.156
Mean Difference (Net)
-2.8
2-Sided
95
-6.64
1.07
Other
Dose finding study
OG001
OG008
SBP
ANCOVA
0.127
Mean Difference (Net)
-3.1
2-Sided
95
-7.11
0.89
Other
Dose finding study
OG002
OG008
SBP
ANCOVA
0.002
Mean Difference (Net)
-6.5
2-Sided
95
-10.52
-2.42
Other
Dose finding study
OG003
OG008
SBP
ANCOVA
0.089
Mean Difference (Net)
-2.7
2-Sided
95
-5.86
0.42
Other
Dose finding study
OG004
OG008
SBP
ANCOVA
0.245
Mean Difference (Net)
-2.3
2-Sided
95
-6.12
1.57
Other
Dose finding study
OG005
OG008
SBP
ANCOVA
0.678
Mean Difference (Net)
-0.8
2-Sided
95
-4.65
3.02
Other
Dose finding study
OG006
OG008
SBP
ANCOVA
0.040
Mean Difference (Net)
-4.1
2-Sided
95
-8.07
-0.19
Other
Dose finding study
OG007
OG008
SBP
ANCOVA
0.038
Mean Difference (Net)
-3.4
2-Sided
95
-6.61
-0.19
Other
Dose finding study
OG000
OG008
DBP
ANCOVA
0.601
Mean Difference (Net)
-0.7
2-Sided
95
-3.38
1.96
Other
Dose finding study
OG001
OG008
DBP
ANCOVA
0.760
Mean Difference (Net)
-0.4
2-Sided
95
-3.20
2.34
Other
Dose finding study
OG002
OG008
DBP
ANCOVA
0.051
Mean Difference (Net)
-2.8
2-Sided
95
-5.60
0.01
Other
Dose finding study
OG003
OG008
DBP
ANCOVA
0.105
Mean Difference (Net)
-1.8
2-Sided
95
-3.98
0.38
Other
Dose finding study
OG004
OG008
DBP
ANCOVA
0.820
Mean Difference (Net)
0.3
2-Sided
95
-2.36
2.98
Other
Dose finding study
OG005
OG008
DBP
ANCOVA
0.157
Mean Difference (Net)
-1.9
2-Sided
95
-4.58
0.74
Other
Dose finding study
OG006
OG008
DBP
ANCOVA
0.859
Mean Difference (Net)
-0.2
2-Sided
95
-2.99
2.49
Other
Dose finding study
OG007
OG008
DBP
ANCOVA
0.054
Mean Difference (Net)
-2.2
2-Sided
95
-4.41
0.04
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Title
Measurements
OG000208.6(101.85 to 315.40)
OG001134.6(-8.69 to 277.85)
OG002377.0(206.19 to 547.90)
OG003306.1(199.59 to 412.62)
OG004183.0(32.37 to 333.70)
OG005193.8(82.22 to 305.31)
OG006241.3(135.13 to 347.30)
OG007308.9(198.27 to 419.53)
OG008-17.8(-94.20 to 58.61)
OG00926.8(-30.03 to 83.70)
OG010122.5(69.82 to 175.26)
OG011248.0(137.72 to 358.33)
OG012-148.9(-269.62 to -28.10)
OG003
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG000158
OG001163
OG00239
OG00334
Title
Denominators
Categories
Title
Measurements
OG000-0.2(-0.70 to 0.33)
OG001-0.2(-0.68 to 0.35)
OG002-2.4(-3.47 to -1.33)
OG0030.4(-0.74 to 1.55)
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
OG003
ANCOVA
0.355
Median Difference (Net)
-0.6
2-Sided
95
-1.84
0.66
Other
Dose finding study
OG001
OG003
ANCOVA
0.373
Mean Difference (Net)
-0.6
2-Sided
95
-1.83
0.69
Other
Dose finding study
OG002
OG003
ANCOVA
<0.001
Mean Difference (Net)
-2.8
2-Sided
95
-4.36
-1.24
Other
Dose finding study
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00316
ParticipantsOG0049
ParticipantsOG00513
ParticipantsOG00638
ParticipantsOG00720
ParticipantsOG00826
Title
Measurements
OG00049.6± 25.08
OG00133.1± 29.65
OG00240.2± 21.55
OG003
Week 24 (Timepoint 1)
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00238
ParticipantsOG00377
Week 24 (Timepoint 2)
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Week 24 (Timepoint 3)
ParticipantsOG00038
ParticipantsOG00138
ParticipantsOG00238
ParticipantsOG00377
OG003
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG000158
OG001163
OG00239
OG00334
Title
Denominators
Categories
Baseline
ParticipantsOG00033
ParticipantsOG00140
ParticipantsOG00211
ParticipantsOG00313
Title
Measurements
OG0004.8± 3.02
OG0015.0± 2.84
OG0024.6± 0.91
OG003
Week 48(Timepoint 1)
ParticipantsOG00026
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG0039
Week 48(Timepoint 2)
ParticipantsOG00026
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG0039
Week 48(Timepoint 3)
ParticipantsOG00026
ParticipantsOG00133
ParticipantsOG00210
ParticipantsOG0039
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00316
ParticipantsOG0049
ParticipantsOG00514
ParticipantsOG0069
ParticipantsOG00721
ParticipantsOG00826
Title
Measurements
OG000282.1± 128.10
OG001240.5± 74.64
OG002254.5± 105.70
OG003
Week 24 (Timepoint 1)
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG00310
Week 24 (Timepoint 2)
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG00310
Week 24 (Timepoint 3)
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG00310
OG003
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG000158
OG001163
OG00239
OG00334
Title
Denominators
Categories
Baseline
ParticipantsOG00036
ParticipantsOG00142
ParticipantsOG00212
ParticipantsOG00313
Title
Measurements
OG00027.6± 11.46
OG00130.5± 11.63
OG00228.6± 14.11
OG003
Week 48 (Timepoint 1)
ParticipantsOG00030
ParticipantsOG00135
ParticipantsOG00212
ParticipantsOG0039
Week 48 (Timepoint 2)
ParticipantsOG00030
ParticipantsOG00135
ParticipantsOG00212
ParticipantsOG0039
Week 48(Timepoint 3)
ParticipantsOG00030
ParticipantsOG00135
ParticipantsOG00212
ParticipantsOG0039
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Apoliprotein A1
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
ParticipantsOG00436
ParticipantsOG00538
ParticipantsOG00635
ParticipantsOG00771
ParticipantsOG00878
ParticipantsOG009151
ParticipantsOG010152
ParticipantsOG01136
ParticipantsOG01234
Title
Measurements
OG0008.9(4.26 to 13.61)
OG0018.13(3.27 to 13.30)
OG00210.7(5.38 to 15.97)
OG003
Apoliprotein B
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Title
Measurements
OG0000.99(0.78 to 1.25)
OG0011.06(0.83 to 1.36)
OG0021.31(1.01 to 1.69)
OG0030.98(0.83 to 1.16)
OG0041.02(0.80 to 1.30)
OG0050.93(0.74 to 118)
OG0061.00(0.78 to 1.27)
OG0070.98(0.83 to 1.17)
OG0080.92(0.78 to 1.09)
OG0090.95(0.85 to 1.06)
OG0100.93(0.83 to 1.04)
OG0110.96(0.77 to 1.20)
OG0121.07(0.84 to 1.36)
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
OG008
ANCOVA
0.632
Mean Difference (Net)
1.07
2-Sided
95
0.81
1.42
Other
Dose finding study
OG001
OG008
ANCOVA
0.352
Mean Difference (Net)
1.15
2-Sided
95
0.86
1.55
Other
Dose finding study
OG002
OG008
ANCOVA
0.027
Mean Difference (Net)
1.41
2-Sided
95
1.04
1.92
Other
Dose finding study
OG003
OG008
ANCOVA
0.587
Mean Difference (Net)
1.07
2-Sided
95
0.85
1.35
Other
Dose finding study
OG004
OG008
ANCOVA
0.508
Mean Difference (Net)
1.10
2-Sided
95
0.82
1.47
Other
Dose finding study
OG005
OG008
ANCOVA
0.945
Mean Difference (Net)
1.01
2-Sided
95
0.76
1.34
Other
Dose finding study
OG006
OG008
ANCOVA
0.602
Mean Difference (Net)
1.08
2-Sided
95
0.81
1.45
Other
Dose finding study
OG007
ANCOVA
0.612
Mean Difference (Net)
1.06
2-Sided
95
0.84
1.35
Other
Dose finding study
OG009
OG012
ANCOVA
0.382
Median Difference (Net)
0.89
2-Sided
95
0.68
1.16
Other
Dose finding study
OG010
OG012
ANCOVA
0.310
Median Difference (Net)
0.87
2-Sided
95
0.67
1.14
Other
Dose finding study
OG011
OG012
ANCOVA
0.525
Mean Difference (Net)
0.90
2-Sided
95
0.65
1.25
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
OG008
Placebo (Epoch 3)
Matching placebo tablets for 24 weeks
OG009
LIK066 qd/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG010
LIK066 Bid/LIK066 35mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG011
Placebo/LIK066 25mg qd (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
OG012
Placebo/Placebo (Epoch 4)
Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00638
OG00776
OG00878
OG009158
OG010163
OG01139
OG01234
Title
Denominators
Categories
Triglycerides (TG)
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
ParticipantsOG00437
ParticipantsOG00538
ParticipantsOG00638
ParticipantsOG00771
ParticipantsOG00878
ParticipantsOG009150
ParticipantsOG010149
ParticipantsOG01136
ParticipantsOG01234
Title
Measurements
OG000-3.8(-14.91 to 7.26)
OG0011.3(-11.19 to 13.80)
OG002-11.5(-24.03 to .093)
OG003
Total Cholesterol (TC)
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
HDL Cholesterol
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
LDL Cholesterol
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00232
ParticipantsOG00377
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
OG008
Triglycerides (TG)
ANCOVA
0.254
Mean Difference (Net)
-7.9
2-Sided
95
-21.37
5.65
Other
Dose finding study
OG001
OG008
Triglycerides (TG)
ANCOVA
0.716
Mean Difference (Net)
-2.7
2-Sided
95
-17.44
11.99
Other
Dose finding study
OG002
OG008
Triglycerides (TG)
ANCOVA
0.038
Mean Difference (Net)
-15.6
2-Sided
95
-30.30
-0.86
Other
Dose finding study
OG003
OG008
Triglycerides (TG)
ANCOVA
0.213
Mean Difference (Net)
-7.0
2-Sided
95
-18.15
4.06
Other
Dose finding study
OG004
OG008
Triglycerides (TG)
ANCOVA
0.806
Mean Difference (Net)
-1.7
2-Sided
95
-15.38
11.96
Other
Dose finding study
OG005
OG008
Triglycerides (TG)
ANCOVA
0.739
Mean Difference (Net)
-2.3
2-Sided
95
-15.80
11.21
Other
Dose finding study
OG006
OG008
Triglycerides (TG)
ANCOVA
0.837
Mean Difference (Net)
1.4
2-Sided
95
-12.36
15.26
Other
Dose finding study
OG007
OG008
Triglycerides (TG)
ANCOVA
0.049
Mean Difference (Net)
-11.4
2-Sided
95
-22.71
-0.07
Other
OG000
OG008
Total Cholesterol (TC)
ANCOVA
0.764
Median Difference (Net)
1.3
2-Sided
95
-7.22
9.82
Other
Dose finding study
OG001
OG008
Total Cholesterol (TC)
ANCOVA
0.571
Mean Difference (Net)
2.6
2-Sided
95
-6.43
11.63
Other
Dose finding study
OG002
OG008
Total Cholesterol (TC)
ANCOVA
0.987
Mean Difference (Net)
0.1
2-Sided
95
-9.30
9.46
Other
Dose finding study
OG003
OG008
Total Cholesterol (TC)
ANCOVA
0.006
Mean Difference (Net)
9.9
2-Sided
95
2.85
16.87
Other
Dose finding study
OG004
OG008
Total Cholesterol (TC)
ANCOVA
0.463
Mean Difference (Net)
-3.3
2-Sided
95
-12.03
5.48
Other
Dose finding study
OG005
OG008
Total Cholesterol (TC)
ANOVA
0.925
Mean Difference (Net)
0.4
2-Sided
95
-8.18
9.01
Other
Dose finding study
OG006
OG008
Total Cholesterol (TC)
ANCOVA
0.711
Mean Difference (Net)
1.7
2-Sided
95
-7.19
10.53
Other
Dose finding study
OG007
OG008
Total Cholesterol (TC)
ANCOVA
0.265
Mean Difference (Net)
4.1
2-Sided
95
-3.10
11.26
Other
Dose finding study
OG000
OG008
HDL Cholesterol
ANCOVA
0.995
Median Difference (Net)
0.0
2-Sided
95
-7.31
7.36
Other
Dose finding study
OG001
OG008
HDL Cholesterol
ANCOVA
0.288
Mean Difference (Net)
4.1
2-Sided
95
-3.52
11.81
Other
Dose finding study
OG002
OG008
HDL Cholesterol
ANCOVA
0.269
Mean Difference (Net)
4.5
2-Sided
95
-3.50
12.50
Other
Dose finding study
OG003
OG008
HDL Cholesterol
ANCOVA
0.018
Median Difference (Net)
7.3
2-Sided
95
1.23
13.27
Other
Dose finding study
OG004
OG008
HDL Cholesterol
ANCOVA
0.565
Median Difference (Net)
2.2
2-Sided
95
-5.32
9.73
Other
Dose finding study
OG005
OG008
HDL Cholesterol
ANCOVA
0.649
Mean Difference (Net)
1.7
2-Sided
95
-5.67
9.09
Other
Dose finding study
OG006
OG008
HDL Cholesterol
ANCOVA
0.847
Mean Difference (Net)
0.7
2-Sided
95
-6.87
8.36
Other
Dose finding study
OG007
OG008
HDL Cholesterol
ANCOVA
0.020
Mean Difference (Net)
7.3
2-Sided
95
1.14
13.43
Other
Dose finding study
OG000
OG008
LDL Cholesterol
ANCOVA
0.579
Mean Difference (Net)
-3.8
2-Sided
95
-17.09
9.57
Other
Dose finding study
OG001
OG008
LDL Cholesterol
ANCOVA
0.487
Mean Difference (Net)
5.0
2-Sided
95
-9.08
19.02
Other
OG002
OG008
LDL Cholesterol
ANCOVA
0.561
Mean Difference (Net)
-4.3
2-Sided
95
-18.96
10.30
Other
Dose finding study
OG003
OG008
LDL Cholesterol
ANCOVA
0.097
Mean Difference (Net)
9.3
2-Sided
95
-1.68
20.25
Other
OG004
OG008
LDL Cholesterol
ANCOVA
0.227
Mean Difference (Net)
-8.4
2-Sided
95
-22.10
5.26
Other
Dose finding study
OG005
OG008
LDL Cholesterol
ANCOVA
0.580
Mean Difference (Net)
-3.8
2-Sided
95
-17.22
9.64
Other
Dose finding study
OG006
OG008
LDL Cholesterol
ANCOVA
0.494
Mean Difference (Net)
-4.8
2-Sided
95
-18.67
9.03
Other
Dose finding study
OG007
OG008
LDL Cholesterol
ANCOVA
0.782
Mean Difference (Net)
-1.6
2-Sided
95
-12.81
9.65
Other
Dose finding study
OG009
OG012
Triglycerides (TG)
ANCOVA
0.816
Mean Difference (Net)
1.9
2-Sided
95
-13.82
17.54
Other
Dose finding study
OG010
OG012
Triglycerides (TG)
ANCOVA
0.341
Mean Difference (Net)
8.02
2-Sided
95
-8.13
23.42
Other
Dose finding study
OG011
OG012
Triglycerides (TG)
ANCOVA
0.566
Median Difference (Net)
9.99
2-Sided
95
-25.39
13.91
Other
Dose finding study
OG009
OG012
Total Cholesterol (TC)
ANCOVA
0.405
Mean Difference (Net)
2.98
2-Sided
95
-3.38
8.36
Other
Dose finding study
OG010
OG012
Total Cholesterol (TC)
ANCOVA
0.511
Median Difference (Net)
2.0
2-Sided
95
-3.92
7.87
Other
Dose finding study
OG011
OG012
Total Cholesterol (TC)
ANCOVA
0.506
Mean Difference (Net)
2.5
2-Sided
95
-4.83
9.79
Other
Dose finding study
OG009
OG012
HDL Cholesterol
ANCOVA
0.392
Median Difference (Net)
3.3
2-Sided
95
-4.20
10.70
Other
Dose finding study
OG010
OG012
HDL Cholesterol
ANOVA
0.426
Mean Difference (Net)
3.0
2-Sided
95
-4.45
10.53
Other
Dose finding study
OG011
OG012
HDL Cholesterol
ANCOVA
0.071
Mean Difference (Net)
8.5
2-Sided
95
-0.72
17.80
Other
Dose finding study
OG009
OG012
LDL Cholesterol
ANCOVA
0.498
Mean Difference (Net)
2.9
2-Sided
95
-5.56
11.42
Other
Dose finding study
OG010
OG012
LDL Cholesterol
ANCOVA
0.586
Median Difference (Net)
2.4
2-Sided
95
-6.17
10.90
Other
Dose finding study
OG011
OG012
LDL Cholesterol
ANCOVA
0.696
Mean Difference (Net)
2.1
2-Sided
95
-8.47
12.67
Other
Dose finding study
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00637
OG00776
Title
Denominators
Categories
Title
Measurements
OG00080.0± 97.2
OG001128± 00.0
OG002798± 397
OG0031810± 545
OG00438.6± 5.22
OG00584.2± 19.0
OG006523± 118
OG007811± 367
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00637
OG00776
Title
Denominators
Categories
Title
Measurements
OG0001.00(1.00 to 2.00)
OG0011.00(1.00 to 1.00)
OG0021.01(1.00 to 2.08)
OG0031.02(1.00 to 2.00)
OG0041.00(0.983 to 1.00)
OG0051.00(0.917 to 2.00)
OG0060.992(0.900 to 1.00)
OG0071.00(0.983 to 2.00)
LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks
Units
Counts
Participants
OG00038
OG00138
OG00238
OG00377
OG00438
OG00539
OG00637
OG00776
Title
Denominators
Categories
Title
Measurements
OG000196± 186
OG001275± 000
OG0022280± 522
OG0035700± 1490
OG004105± 17.1
OG005273± 69.3
OG0061520± 277
OG0072190± 841
OG005
LIK066 5mg Bid (Epoch 3)
LIK066 5mg bid (twice daily) dosing frequency for 24 weeks
OG006
LIK066 25mg Bid (Epoch 3)
LIK066 25mg bid (twice daily) dosing frequency for 24 weeks
OG007
LIK066 50mg Bid (Epoch 3)
LIK066 50mg bid (twice daily) dosing frequency for 24 weeks