A Study to Evaluate Efficacy and Safety of LCI699 in Part... | NCT00758524 | Trialant
NCT00758524
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jul 6, 2021Actual
Enrollment
628Actual
Phase
Phase 2
Conditions
Essential Hypertension
Interventions
LCI699
Eplerenone
LCI699-matching Placebo
Eplerenone-matching Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00758524
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLCI699A2201
Secondary IDs
Not provided
Brief Title
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
Official Title
A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Dose Finding Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo After 8 Weeks Treatment in Patients With Essential Hypertension
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2021
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
Sep 11, 2008Actual
Primary Completion Date
Jul 2, 2009Actual
Completion Date
Jul 2, 2009Actual
First Submitted Date
Sep 23, 2008
First Submission Date that Met QC Criteria
Sep 23, 2008
First Posted Date
Sep 25, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
May 17, 2021
Results First Submitted that Met QC Criteria
Jun 11, 2021
Results First Posted Date
Jul 6, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 31, 2012
Certification/Extension First Submitted that Passed QC Review
May 31, 2012
Certification/Extension First Posted Date
Jun 6, 2012Estimated
Last Update Submitted Date
Jun 11, 2021
Last Update Posted Date
Jul 6, 2021Actual
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 study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.
Detailed Description
Not provided
Conditions Module
Conditions
Essential Hypertension
Keywords
Essential hypertension
Phase 2 study
Antihypertensive agent
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
628Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Core Period: LCI699 0.25 mg QD
Experimental
Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
Drug: LCI699
Core Period: LCI699 0.5 mg QD
Experimental
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
Drug: LCI699
Core Period: LCI699 1.0 mg QD
Experimental
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
Drug: LCI699
Core Period: LCI699 0.5 mg BID
Experimental
Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
Drug: LCI699
Core Period: Eplerenone 50 mg BID
Active Comparator
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
Drug: Eplerenone
Core Period: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LCI699
Drug
LCI699 oral capsules
Core Period: LCI699 0.25 mg QD
Core Period: LCI699 0.5 mg BID
Core Period: LCI699 0.5 mg QD
Core Period: LCI699 1.0 mg QD
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Baseline, Week 8
Secondary Outcomes
Measure
Description
Time Frame
Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and non-fertile females.
18-75 years inclusive.
Participants with mild-to-moderate uncomplicated essential hypertension.
Exclusion Criteria:
All women of child bearing potential.
Female participants on hormone replacement therapy.
Severe hypertension.
History or evidence of a secondary form of hypertension.
Known moderate or malignant retinopathy.
History of angina pectoris, myocardial infarction, coronary bypass surgery,ischemic heart disease, surgical or percutaneous arterial intervention of any kind (coronary, carotid or peripheral vessels), stroke, transient ischemic attack (TIA), carotid artery stenosis, aortic aneurysm or peripheral arterial disease.
Type 1 or type 2 diabetes mellitus.
Clinically significant valvular heart disease.
Congestive heart failure (New York Heart Association [NYHA] class II-IV).
Cardiac electrical abnormalities indicating significant risk of safety for participant taking part in the study.
History of malignancy of any organ system, treated or untreated, within the past 5 years.
Liver disease such as cirrhosis or chronic active hepatitis.
Any surgical or medical conditions that may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
Any surgical or medical conditions, not identified in the protocol that in the opinion of the investigator or the monitor, place the participant at higher risk from his/her participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the trial period.
Participant unwilling or not able to discontinue safely the use of current antihypertensive medications during the study period
Any contraindication or history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
Chronic oral or parenteral corticosteroid treatment.
Treatment with potassium supplement or potassium sparing diuretics.
Treatment with potent cytochrome P450 3A4 (CYP3A4) inhibitors during the study period.
Use of other investigational drugs at Visit 1, or within 30 days or 5 half-lives of Visit 1, whichever is longer, unless local health authority guidelines mandate a longer period.
Serum potassium > 5.2 milliequivalents per liter (mEq/L) or < 3.5 mEq/L at Visit 1.
Serum sodium < 132 mEq/L at Visit 1.
Aspartate aminotransferase (ALT) or alanine aminotransferase (AST) > 2 times the upper limit of the normal range (ULN) at Visit 1.
Bilirubin (total) > 1.5 x ULN at Visit 1.
Modification of diet in renal disease estimated glomerular filtration rate (MDRD eGFR) < 60 milliliters per minute (ml/min)/1.73 m^2 at Visit 1.
Other clinically significant laboratory abnormalities, confirmed by repeat measurements, at Visit 1.
History of active substance abuse (including alcohol).
Schumacher CD, Steele RE, Brunner HR. Aldosterone synthase inhibition for the treatment of hypertension and the derived mechanistic requirements for a new therapeutic strategy. J Hypertens. 2013 Oct;31(10):2085-93. doi: 10.1097/HJH.0b013e328363570c.
Calhoun DA, White WB, Krum H, Guo W, Bermann G, Trapani A, Lefkowitz MP, Menard J. Effects of a novel aldosterone synthase inhibitor for treatment of primary hypertension: results of a randomized, double-blind, placebo- and active-controlled phase 2 trial. Circulation. 2011 Nov 1;124(18):1945-55. doi: 10.1161/CIRCULATIONAHA.111.029892. Epub 2011 Oct 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
A total of 628 participants were enrolled in the study. Out of 628, only 524 participants with essential hypertension were randomized to receive LCI699 or eplerenone in comparison with placebo for 8 weeks, followed by a randomized withdrawal period to either continue the treatment arm they were randomized to or to take placebo for one additional week (Week 9).
Recruitment Details
Participants took part at 84 investigative sites in Argentina, Australia, France, Germany, Netherlands, Romania, Spain, Sweden, and the United States from 11 September 2008 to 02 July 2009.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
FG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
FG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
FG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
FG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
FG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
FG006
Withdrawal Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG007
Withdrawal Period: LCI699 0.25 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG008
Withdrawal Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG009
Withdrawal Period: LCI699 0.5 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG010
Withdrawal Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG011
Withdrawal Period: LCI699 1.0 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
FG012
Withdrawal Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
FG013
Withdrawal Period: LCI699 0.5 mg BID Placebo
Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
FG014
Withdrawal Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
FG015
Withdrawal Period: Eplerenone 50 mg BID Placebo
Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
FG016
Withdrawal Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Periods
Title
Milestones
Reasons Not Completed
Core Period (Week 0 to Week 8)
Type
Comment
Milestone Data
STARTED
FG00092 subjects
FG00188 subjects
FG00286 subjects
FG00397 subjectsOne participant in this arm group was randomized twice and was excluded from Full Analysis Set.
FG004
Treated
Safety Set included participants who received at least 1 dose of study drug.
FG00092 subjects
FG00187 subjects
FG00287 subjectsOne participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set.
FG003
COMPLETED
FG00084 subjects
FG00181 subjects
FG00277 subjects
FG00390 subjects
FG004
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG0029 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0003 subjects
FG0012 subjects
FG0024 subjects
FG003
Withdrawal Period (Week 8 to Week 9)
Type
Comment
Milestone Data
STARTED
Participants that started the withdrawal period included those who received at least one dose of the study drug from Week 8 to Week 9 (Randomized Withdrawal Safety Set).
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Full Analysis Set (FAS) population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
BG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Core Period: Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Week 8 Last Observation Carried Forward (LOCF), as Measured by Office Blood Pressure (OBP)
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Error
mm Hg
Baseline, Week 8
Adverse Events Module
Frequency Threshold
1
Time Frame
AEs: From start of the study drug treatment up to 9 weeks; SAE: From signing of the informed consent up to 9 weeks
Description
Core Period: Safety Set included all the participants who received at least 1 dose of study drug. One participant from LCI699 0.5 mg QD was randomized to LCI699 1.0 mg QD and received LCI699 1.0 mg QD, thus was included in this arm in the Safety Set. Withdrawal period: Randomized Withdrawal Safety Set included participants who received at least one dose of the study drug from Week 8 to Week 9.
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
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Drug: LCI699-matching Placebo
Drug: Eplerenone-matching Placebo
Withdrawal Period: LCI699 0.25 mg QD
Experimental
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699
Withdrawal Period: LCI699 0.25 mg QD Placebo
Placebo Comparator
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699-matching Placebo
Withdrawal Period: LCI699 0.5 mg QD
Experimental
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699
Withdrawal Period: LCI699 0.5 mg QD Placebo
Placebo Comparator
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699-matching Placebo
Withdrawal Period: LCI699 1.0 mg QD
Experimental
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699
Withdrawal Period: LCI699 1.0 mg QD Placebo
Placebo Comparator
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699-matching Placebo
Withdrawal Period: LCI699 0.5 mg BID
Experimental
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699
Withdrawal Period: LCI699 0.5 mg BID Placebo
Placebo Comparator
Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699-matching Placebo
Withdrawal Period: Eplerenone 50 mg BID
Active Comparator
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
Drug: Eplerenone
Withdrawal Period: Eplerenone 50 mg BID Placebo
Placebo Comparator
Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
Drug: Eplerenone-matching Placebo
Withdrawal Period: Placebo
Placebo Comparator
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Drug: LCI699-matching Placebo
Drug: Eplerenone-matching Placebo
Withdrawal Period: LCI699 0.25 mg QD
Withdrawal Period: LCI699 0.5 mg BID
Withdrawal Period: LCI699 0.5 mg QD
Withdrawal Period: LCI699 1.0 mg QD
Eplerenone
Drug
Eplerenone oral capsules
Core Period: Eplerenone 50 mg BID
Withdrawal Period: Eplerenone 50 mg BID
LCI699-matching Placebo
Drug
LCI699-matching placebo oral capsules
Core Period: Placebo
Withdrawal Period: LCI699 0.25 mg QD Placebo
Withdrawal Period: LCI699 0.5 mg BID Placebo
Withdrawal Period: LCI699 0.5 mg QD Placebo
Withdrawal Period: LCI699 1.0 mg QD Placebo
Withdrawal Period: Placebo
Eplerenone-matching Placebo
Drug
Eplerenone-matching placebo oral capsules
Core Period: Placebo
Withdrawal Period: Eplerenone 50 mg BID Placebo
Withdrawal Period: Placebo
Baseline, Week 8
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
Baseline, Week 8
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
Baseline, Week 8
Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM)
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.
Baseline, Week 8
Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.
Baseline, Week 8
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Baseline, every hour up to 24 hours post-dose at Week 8
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
Baseline, every hour up to 24 hours post-dose at Week 8
Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8
Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.
Baseline, Week 8
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF
MSDBP response was defined as the percentage of participants with a MSDBP <90 mmHg or a >=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP <90 mmHg.
Baseline, Week 8
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF
MSSBP response was defined as the percentage of participants with a MSSBP <140 mmHg or a >=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP <140 mmHg.
Baseline, Week 8
Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test
The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was <500 nanomoles per liter (nmol/L) at 1 hour after the injection.
Baseline, 1 hour post-dose at Week 8
Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.
From Week 8 to Week 9
Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.
From Week 8 to Week 9
84 subjects
FG00577 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
97 subjects
FG00484 subjects
FG00576 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
75 subjects
FG00567 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
9 subjects
FG00510 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0043 subjects
FG0055 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Withdrawal by Subject
FG0003 subjects
FG0010 subjects
FG0022 subjects
FG0033 subjects
FG0041 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Adverse Event
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Administrative Problems
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Abnormal Laboratory Values
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Abnormal Test Procedure Results
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Reason not Specified
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG00646 subjects
FG00738 subjects
FG00844 subjects
FG00937 subjectsOne participant randomized to Placebo arm in Withdrawal Period received LCI699 0.5 mg QD and was counted in LCI699 0.5 mg QD arm in the Randomized Withdrawal Safety Set.
FG01041 subjects
FG01137 subjectsOne participant randomized to LCI699 0.5 mg BID in the core period received LCI699 1.0 mg QD and was considered in the LCI699 1.0 mg QD arm in Randomized Withdrawal Safety Set.
FG01245 subjects
FG01345 subjects
FG01439 subjects
FG01536 subjects
FG01666 subjects
Randomized Withdrawal Set
Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00645 subjects
FG00738 subjects
FG00843 subjects
FG00937 subjects
FG01041 subjects
FG01136 subjects
FG01245 subjects
FG01344 subjects
FG01439 subjects
FG01536 subjects
FG01667 subjectsOne participant randomized to Placebo arm in Withdrawal Period received LCI699 0.5 mg QD and was counted in LCI699 0.5 mg QD arm in the Randomized Withdrawal Safety Set. However, this participant was counted in the Placebo arm (N=67) in the Randomized Withdrawal Set.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00645 subjects
FG00738 subjects
FG00842 subjects
FG00937 subjects
FG01041 subjects
FG01137 subjects
FG01245 subjects
FG01345 subjects
FG01439 subjects
FG01536 subjects
FG01666 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Type
Comment
Reasons
Unsatisfactory Therapeutic Effect
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
BG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
BG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
BG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
BG006
Total
Total of all reporting groups
92
BG00187
BG00286
BG00396
BG00484
BG00577
BG006522
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00092
ParticipantsBG00187
ParticipantsBG00286
ParticipantsBG00396
ParticipantsBG00484
ParticipantsBG00577
ParticipantsBG006522
Title
Measurements
BG00053.9± 10.5
BG00154.8± 7.8
BG00254.5± 9.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00092
ParticipantsBG00187
ParticipantsBG00286
ParticipantsBG00396
ParticipantsBG00484
ParticipantsBG00577
ParticipantsBG006522
Title
Measurements
Female
BG00029
BG00129
BG00231
BG003
Blood Pressure
Ambulatory blood pressure monitoring (ABPM) measured a participant's blood pressure (BP) over 24-hour period readings using an automated validated monitoring device at Baseline. The 24-hour ambulatory DBP and 24-hour ambulatory SBP were calculated by taking the mean of all ambulatory DBP and SBP readings respectively for the 24-hour period.
Only participants with available ABPM measurements were included for assessment of 24-hour ambulatory DBP and 24-hour SBP.
Mean
Standard Deviation
millimeters of mercury (mm Hg)
Title
Denominators
Categories
Clinic Systolic Blood Pressure (SBP)
ParticipantsBG00092
ParticipantsBG00187
ParticipantsBG00286
ParticipantsBG00396
ParticipantsBG00484
ParticipantsBG00577
ParticipantsBG006522
Title
Measurements
BG000157.72± 12.163
BG001157.04± 11.580
BG002159.24± 10.415
BG003
Clinic Diastolic Blood pressure (DBP)
ParticipantsBG00092
ParticipantsBG00187
ParticipantsBG00286
ParticipantsBG00396
24-hour Ambulatory SBP
ParticipantsBG00079
ParticipantsBG00176
ParticipantsBG00280
ParticipantsBG00378
24-hour Ambulatory DBP
ParticipantsBG00079
ParticipantsBG00176
ParticipantsBG00280
ParticipantsBG00378
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG00396
OG00484
OG00576
Title
Denominators
Categories
Title
Measurements
OG000-4.47± 0.60
OG001-5.50± 0.57
OG002-7.11± 0.88
OG003-4.25± 0.95
OG004-7.49± 0.97
OG005-3.22± 0.87
Secondary
Core Period: Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 LOCF, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Error
mm Hg
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG000-9.00± 1.40
OG001-10.69± 0.98
OG002-11.93± 1.44
OG003
Secondary
Core Period: Number of Participants With Adverse Event (AEs), Serious Adverse Events (SAEs), and Deaths
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Safety Set included all the participants who received at least 1 dose of study drug.
Posted
Count of Participants
Participants
AEs: From start of the study drug treatment up to 8 weeks; SAE: From signing of the informed consent up to 8 weeks
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00187
OG00287
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00023
OG00122
OG00224
OG003
Secondary
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSDBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and region as factors and baseline MSDBP level as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Error
mm Hg
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.47± 0.60
OG001-5.50± 0.57
OG002-7.11± 0.88
OG003
Secondary
Core Period: Dose Response Relationship of LCI699 as Measured by Change From Baseline in MSSBP at Week 8
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an ANCOVA with treatment and region as factors and baseline MSSBP levels as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Error
mm Hg
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG003
Title
Denominators
Categories
Title
Measurements
OG000-9.00± 1.40
OG001-10.69± 0.98
OG002-11.93± 1.44
OG003
Secondary
Core Period: Change From Baseline in Mean 24 Hour Ambulatory SBP at Week 8 as Measured by Ambulatory Blood Pressure Monitoring (ABPM)
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory SBP readings for the 24-hour period.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting SBP assessment.
Posted
Least Squares Mean
Standard Error
mm Hg
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00062
OG00159
OG00268
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.15± 1.20
OG001-4.90± 1.22
OG002-7.73± 1.13
OG003
Secondary
Core Period: Change From Baseline in Mean 24 Hour Ambulatory DBP at Week 8, as Measured by ABPM
An ABPM measured a participant's BP over a 24-hour period readings using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory DBP readings for the 24-hour period.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants signifies the number of participants in the FAS who have a Baseline and a Week 8 mean 24-hour ABPM sitting DBP assessment.
Posted
Least Squares Mean
Standard Error
mm Hg
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00062
OG00159
OG00268
OG003
Title
Denominators
Categories
Title
Measurements
OG000-4.03± 0.91
OG001-2.44± 0.92
OG002-4.96± 0.86
OG003
Secondary
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory DBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.
Posted
Least Squares Mean
Standard Error
ratio
Baseline, every hour up to 24 hours post-dose at Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00187
OG00286
OG003
Title
Denominators
Categories
Week 8, Hour 1
Title
Measurements
OG0003.91± 1.466
OG0012.95± 1.541
OG0020.27± 1.389
OG003
Secondary
Core Period: Trough to Hour Ratio for Change From Baseline in 24-hour Mean Ambulatory SBP at Week 8
Trough to peak ratios were derived from an ANCOVA model containing treatment, region, hour, treatment by hour interaction as factors with Baseline as a covariate.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations.
Posted
Least Squares Mean
Standard Error
ratio
Baseline, every hour up to 24 hours post-dose at Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00187
OG00286
OG003
Title
Denominators
Categories
Week 8, Hour 1
Title
Measurements
OG000-0.54± 1.767
OG0010.09± 1.859
OG002-4.51± 1.674
OG003
Secondary
Core Period: Change From Baseline in Plasma Aldosterone Levels at Week 8
Change from baseline was analyzed using plasma aldosterone values measured at Baseline and Week 8.
Safety Set included all the participants who received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
picomoles per liter (pmol/L)
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00071
OG00169
OG00270
OG003
Title
Denominators
Categories
Title
Measurements
OG000-21.5± 122
OG001-20.0± 156
OG002-9.9± 266
OG003
Secondary
Core Period: Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8 LOCF
MSDBP response was defined as the percentage of participants with a MSDBP <90 mmHg or a >=10 mmHg reduction from Baseline. MSDBP control was defined as the percentage of participants with a MSDBP <90 mmHg.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG003
Title
Denominators
Categories
MSDBP Response
Title
Measurements
OG00039.1
OG00134.1
OG00250.0
OG003
Secondary
Core Period: Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8 LOCF
MSSBP response was defined as the percentage of participants with a MSSBP <140 mmHg or a >=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP <140 mmHg.
FAS population included all randomized participants or participants that met the inclusion criteria as described in study documentation protocol excluding misrandomized participants or participants with protocol violations. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Number
percentage of participants
Baseline, Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00092
OG00185
OG00286
OG003
Title
Denominators
Categories
MSSBP Response
Title
Measurements
OG00039.1
OG00137.6
OG00248.8
OG003
Secondary
Core Period: Change From Baseline in Plasma Cortisol Levels by Adrenocorticotropic Hormone (ACTH) Stimulation Test
The ACTH stimulation cortisol test was a standard procedure to measure the ability of adrenal cortex to respond to exogenous ACTH and directly assess the adrenal reserve. Serum cortisol concentrations at 1 hour after injection were measured to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration was <500 nanomoles per liter (nmol/L) at 1 hour after the injection.
ACTH subset population included all participants prior to treatment with LCI699 and at the end of the treatment interval (Week 8). Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure at the given timepoint
Posted
Mean
Standard Deviation
nanomoles per liter (nmol/L)
Baseline, 1 hour post-dose at Week 8
ID
Title
Description
OG000
Core Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
OG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
OG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
Units
Counts
Participants
OG00020
OG00123
OG00228
OG003
Title
Denominators
Categories
Title
Measurements
OG000729.20± 123.753
OG001692.74± 117.645
OG002604.46± 125.017
OG003
Secondary
Withdrawal Period: Change From Week 8 to Week 9 in MSDBP at Week 9, as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSDBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSDBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSDBP level as a covariate.
Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
mm Hg
From Week 8 to Week 9
ID
Title
Description
OG000
Withdrawal Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG001
Withdrawal Period: LCI699 0.25 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG002
Withdrawal Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG003
Withdrawal Period: LCI699 0.5 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG004
Withdrawal Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG005
Withdrawal Period: LCI699 1.0 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG006
Withdrawal Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG007
Withdrawal Period: LCI699 0.5 mg BID Placebo
Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG008
Withdrawal Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG009
Withdrawal Period: Eplerenone 50 mg BID Placebo
Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG010
Withdrawal Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Units
Counts
Participants
OG00045
OG00138
OG00243
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.5± 0.99
OG0010.5± 1.08
OG0021.6± 1.01
OG003
Secondary
Withdrawal Period: Change From Week 8 to Week 9 in MSSBP at Week 9 as Measured by OBP
Automated arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the Guidelines for management of hypertension: report of the 4th working party of the British Hypertension Society, 2004-BHS IV, using an automated BP device (such as the Omron BP monitor). The change in the MSSBP was calculated comparing the Week 9 readings to the readings taken at Week 8 (Baseline). The change from Week 8 to week 9 in MSSBP was analyzed using an ANCOVA with treatment and region as factors and Week 8 MSSBP level as a covariate.
Randomized Withdrawal Set included all participants with post-baseline blood pressure measurements from Week 8 to Week 9 only. Overall number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.
Posted
Least Squares Mean
Standard Error
mm Hg
From Week 8 to Week 9
ID
Title
Description
OG000
Withdrawal Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG001
Withdrawal Period: LCI699 0.25 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG002
Withdrawal Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG003
Withdrawal Period: LCI699 0.5 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG004
Withdrawal Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG005
Withdrawal Period: LCI699 1.0 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
OG006
Withdrawal Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG007
Withdrawal Period: LCI699 0.5 mg BID Placebo
Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG008
Withdrawal Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG009
Withdrawal Period: Eplerenone 50 mg BID Placebo
Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
OG010
Withdrawal Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
Units
Counts
Participants
OG00045
OG00138
OG00243
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.3± 1.66
OG0013.3± 1.80
OG0020.5± 1.69
OG003
0
92
1
92
22
92
EG001
Core Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks.
0
87
0
87
22
87
EG002
Core Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks.
0
87
0
87
24
87
EG003
Core Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 8 weeks.
0
97
0
97
27
97
EG004
Core Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks.
0
84
0
84
26
84
EG005
Core Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks.
0
76
1
76
23
76
EG006
Withdrawal Period: LCI699 0.25 mg QD
Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
46
0
46
2
46
EG007
Withdrawal Period: LCI699 0.25 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
38
0
38
1
38
EG008
Withdrawal Period: LCI699 0.5 mg QD
Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
44
0
44
1
44
EG009
Withdrawal Period: LCI699 0.5 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
37
0
37
0
37
EG010
Withdrawal Period: LCI699 1.0 mg QD
Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
41
0
41
3
41
EG011
Withdrawal Period: LCI699 1.0 mg QD Placebo
Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9).
0
37
0
37
5
37
EG012
Withdrawal Period: LCI699 0.5 mg BID
Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
0
45
0
45
4
45
EG013
Withdrawal Period: LCI699 0.5 mg BID Placebo
Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
0
45
0
45
3
45
EG014
Withdrawal Period: Eplerenone 50 mg BID
Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
0
39
0
39
2
39
EG015
Withdrawal Period: Eplerenone 50 mg BID Placebo
Participants received eplerenone-matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9).
0
36
0
36
0
36
EG016
Withdrawal Period: Placebo
Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).
0
66
0
66
3
66
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0131 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Bradycardia
Cardiac disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Palpitations
Cardiac disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0052 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Sinus bradycardia
Cardiac disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tachycardia
Cardiac disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0131 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tachycardia paroxysmal
Cardiac disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Talipes
Congenital, familial and genetic disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Vestibular disorder
Ear and labyrinth disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Conjunctivitis
Eye disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Glaucoma
Eye disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Vision blurred
Eye disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Visual impairment
Eye disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0111 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0012 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Constipation
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0002 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0052 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Dry mouth
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Enterocolitis
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Flatulence
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Gingivitis
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hyperchlorhydria
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Nausea
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0052 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Oral pain
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Toothache
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Vomiting
Gastrointestinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0052 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Asthenia
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0032 affected97 at risk
EG0041 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Chest discomfort
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Fatigue
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0032 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Irritability
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Malaise
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Non-cardiac chest pain
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0002 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Oedema peripheral
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0071 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Pyrexia
General disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Biliary colic
Hepatobiliary disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hepatic steatosis
Hepatobiliary disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Seasonal allergy
Immune system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Acarodermatitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Acute tonsillitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Bronchitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Bronchitis bacterial
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Influenza
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0012 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Nasopharyngitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0012 affected87 at risk
EG0023 affected87 at risk
EG0031 affected97 at risk
EG0044 affected84 at risk
EG0053 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0121 affected45 at risk
EG0131 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Pharyngitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Pneumonia
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Respiratory tract infection viral
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Rhinitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Sialoadenitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0161 affected66 at risk
Sinusitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0022 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tooth abscess
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tracheitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tracheobronchitis
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0011 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Urinary tract infection
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0002 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Viral infection
Infections and infestations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0101 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Joint sprain
Injury, poisoning and procedural complications
MedDRA (unspecified)
Systematic Assessment
EG0002 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0111 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Weight decreased
Investigations
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Gout
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0131 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Increased appetite
Metabolism and nutrition disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0141 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0052 affected76 at risk
EG0061 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0141 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0111 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0161 affected66 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Spinal disorder
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0121 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Tenosynovitis
Musculoskeletal and connective tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Carotid arteriosclerosis
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Carpal tunnel syndrome
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Cervicobrachial syndrome
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0121 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Complex regional pain syndrome
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Dizziness
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0022 affected87 at risk
EG0035 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Dizziness postural
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Headache
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0014 affected87 at risk
EG0021 affected87 at risk
EG0032 affected97 at risk
EG0043 affected84 at risk
EG00510 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0111 affected37 at risk
EG0120 affected45 at risk
EG0131 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Migraine
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Paraesthesia
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Somnolence
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Syncope
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0111 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Trigeminal neuralgia
Nervous system disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0161 affected66 at risk
Anxiety
Psychiatric disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Depression
Psychiatric disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Insomnia
Psychiatric disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0052 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Stress
Psychiatric disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Nocturia
Renal and urinary disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0061 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Ejaculation disorder
Reproductive system and breast disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Menopausal symptoms
Reproductive system and breast disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0101 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0071 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0101 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0042 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0121 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Angioedema
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0021 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0041 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0021 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0081 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Skin odour abnormal
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Skin striae
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0011 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Hypertensive crisis
Vascular disorders
MedDRA (unspecified)
Systematic Assessment
EG0001 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0030 affected97 at risk
EG0040 affected84 at risk
EG0051 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
Raynaud's phenomenon
Vascular disorders
MedDRA (unspecified)
Systematic Assessment
EG0000 affected92 at risk
EG0010 affected87 at risk
EG0020 affected87 at risk
EG0031 affected97 at risk
EG0040 affected84 at risk
EG0050 affected76 at risk
EG0060 affected46 at risk
EG0070 affected38 at risk
EG0080 affected44 at risk
EG0090 affected37 at risk
EG0100 affected41 at risk
EG0110 affected37 at risk
EG0120 affected45 at risk
EG0130 affected45 at risk
EG0140 affected39 at risk
EG0150 affected36 at risk
EG0160 affected66 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.