This Was an Open-label, Single-arm Extension Study (CFTY7... | NCT00731692 | Trialant
NCT00731692
Sponsor
Novartis Pharmaceuticals
Status
Terminated
Last Update Posted
Jun 14, 2017Actual
Enrollment
970Actual
Phase
Phase 3
Conditions
Primary Progressive Multiple Sclerosis
Interventions
FTY720
Placebo
Countries
United States
Australia
Belgium
Canada
Czechia
Denmark
Finland
France
Germany
Hungary
Italy
Netherlands
Poland
Spain
Sweden
Switzerland
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00731692
Obsolete or Duplicate NCT IDs
NCT01779934
Organization Study
CFTY720D2306
Secondary IDs
ID
Type
Description
Link
2007-002627-32
EudraCT Number
Brief Title
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
Official Title
A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis
Acronym
INFORMS
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
May 2017
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The extension study was terminated early after the results of the core study showed the study did not meet primary endpoint; confirmed disability progression
Expanded Access Info
No
Start Date
Jul 28, 2008Actual
Primary Completion Date
Jun 22, 2015Actual
Completion Date
Jun 22, 2015Actual
First Submitted Date
Aug 7, 2008
First Submission Date that Met QC Criteria
Aug 7, 2008
First Posted Date
Aug 11, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 16, 2015
Results First Submitted that Met QC Criteria
May 9, 2017
Results First Posted Date
Jun 14, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 9, 2017
Last Update Posted Date
Jun 14, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment
Drug: FTY720
Placebo
Placebo Comparator
Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization
Drug: Placebo
FTY720D 1.25 mg switch to 0.5 mg
Experimental
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009
Drug: FTY720
Interventions
Name
Type
Description
Arm Group Labels
Other Names
FTY720
Drug
Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily
FTY720D 0.5 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint
3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.
up to 36 months after the last patient was randomized
Secondary Outcomes
Measure
Description
Time Frame
Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General
sign written informed consent prior to participating in the study
25 through 65 years of age inclusive
females of childbearing potential must:
have a negative pregnancy test at Baseline (prior to randomization) and
use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication
Primary Progressive Multiple sclerosis.
diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
time since first reported symptoms between 2 and 10 years
evidence of clinical disability progression in the 2 years prior to Screening
disability status at Screening
EDSS score of 3.5-6.0 inclusive
pyramidal functional system score of 2 or more
25'TWT less than 30 seconds
Extension study Inclusion criteria
Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation.
Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study
Exclusion Criteria:
PPMS specific:
History of relapses/attacks
Progressive neurological disorder other than PPMS
Pure cerebellar syndrome or pure visual progressive syndrome or pure
cognitive progressive syndrome
Presence of spinal cord compression at screening MRI
Relevant history of vitamin B12 deficit
Evidence of syphilis or borreliosis at Screening
Cardiovascular conditions:
Myocardial infarction within the past 6 months or current unstable ischemic heart disease
History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
Severe cardiac failure or cardiac arrest
History of symptomatic bradycardia
Resting pulse <55 bpm pre-dose
History of sick sinus syndrome or sino-atrial heart block
History or presence of second and third degree AV block or an increase QT interval (QTc>440 ms)
Arrythmia requiring treatment with class III antiarrythmic drugs
History of positive tilt test from workout of vasovagal syncope
Hypertension, not controlled with medication
Pulmonary:
Severe respiratory disease or pulmonary fibrosis
TB
Abnormal X-ray, suggestive of active pulmonary disease
Abnormal PFT: <70% of predicted for FEV1 and FVC; <60% for DLCO
Patients receiving chronic (daily) therapies for asthma
Hepatic:
Known history of alcohol abuse, chronic liver or biliary disease
Total or conjugated Brb >ULN, unless in context of Gilbert's syndrome
AP >1.5xULN; ALT/AST >2xULN; GGT>3xULN
Other:
History of chronic disease of the immune system other than MS
Malignancy (other than successfully treated SCC or BCC)
Diabetes Mellitus
Macular Edema present at screening
HIV, Hepatitis C or B, other active infection
History of total lymphoid irradiation or bone marrow transplantation
Serum creatinine >1.7 mg/dl
WBC <3500 cells/mm3
Lymphocyte count <800 cells/mm3
History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
Unable to undergo MRI scans
Participation in any therapeutical clinical research study in the 6 months prior to randomization
Pregnant or lactating women
Drugs requiring wash-out period:
3 months:
Systemic corticosteroids or ACTH
INF-beta
6 months:
Immunosuppressive medication
Immunoglobulins
Monoclonal antibodies
Drugs that exclude participation in the study:
Cladribine
Cyclophosphamide
Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)
Extension study Exclusion criteria
-Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Prior to protocol amendment 147 patients received 1.25mg of FTY720; post protocol amendment 5 not all 147 patients switched to 0.5mg FTY720, only 121 switched and their data is presented under the 0.5mg dose.
Recruitment Details
Patients were randomized equally to receive either fingolimod or placebo. Patients initially randomized to fingolimod 1.25 mg/day or matching placebo groups switched in a blinded manner to fingolimod 0.5 mg/day or continued on placebo after amendment in Nov. 2009. Patients were randomized to receive either fingolimod 0.5 mg/day or placebo..
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
Matching placebo capsules were administered orally once daily
Placebo
up to 36 months after the last patient was randomized
Percent Change From Baseline in Brain Volume at Month 36
The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.
Baseline to month 36
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
up to 36 months after the last patient was randomized
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.
The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
up to 36 months after the last patient was randomized
Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36
Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Baseline to 36 months
Number of Gd-enhancing Lesions at Month 36
Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Baseline to 36 months
Percent Change in Total T2 Lesion Volume From Baseline to Month 36
Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis
Baseline to month 36
Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)
The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score
Baseline, 36 months
Change From Baseline in PRIMUS-Activities
The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).
Baseline, 36 months
Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score
Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).
Baseline, 36 months
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Baseline, 36 months
Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)
The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).
Baseline, 36 months
Blood Concentrations of Fingolimod and Fingolimod-phosphate
Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.
Venous blood samples were collected for the analysis.
Month 3 up to 36 months
Change in MSFC Z-score and Subscale Scores From Baseline to Month 36
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.
Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.
Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.
Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
FG002
Placebo to -FTY 0.5 mg
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
FG000147 subjects
FG001336 subjects
FG002487 subjects
Safety Set (SAF)
FG0000 subjects
FG001336 subjects
FG002487 subjects
Full Analysis Set (FAS)
FG0000 subjects
FG001336 subjects
FG002487 subjects
Pharmacokinetic Analysis Set
FG000102 subjects
FG001249 subjects
FG0020 subjects
Post Protocol Amendment 5 Switch
FG0000 subjects
FG001121 subjectspost protocol amendment 121 patients switch to 0.5 mg dose from 125mg dose
FG0020 subjects
COMPLETED
FG00079 subjects
FG001220 subjects
FG002317 subjects
NOT COMPLETED
FG00068 subjects
FG001116 subjects
FG002170 subjects
Type
Comment
Reasons
Lack of Efficacy
FG00011 subjects
FG00123 subjects
FG00264 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
Death
FG0002 subjects
FG0011 subjects
FG0022 subjects
Lost to Follow-up
FG0001 subjects
FG0013 subjects
FG0023 subjects
Administrative
FG0002 subjects
FG0012 subjects
FG0026 subjects
Abnormal Test Procedure Result
FG0004 subjects
FG0013 subjects
FG0025 subjects
Protocol Violation
FG0004 subjects
FG0015 subjects
FG0028 subjects
Abnormal Lab values
FG0006 subjects
FG00119 subjects
FG0025 subjects
Adverse Event
FG00025 subjects
FG00128 subjects
FG00229 subjects
Withdrawal by Subject
FG00012 subjects
FG00132 subjects
FG00246 subjects
Extension Phase
Type
Comment
Milestone Data
STARTED
FG00074 subjects
FG001196 subjects
FG002301 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00074 subjects
FG001196 subjects
FG002301 subjects
Type
Comment
Reasons
Admin Problems: Terminated # patients
FG00069 subjects
FG001189 subjects
FG002277 subjects
Abnormal test procedure
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
BG001
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
BG002
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000147
BG001336
BG002487
BG003970
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.8± 8.47
BG00148.5± 8.59
BG00248.5± 8.31
BG003
Age, Customized
Number
Particpants
Title
Denominators
Categories
<=30
Title
Measurements
BG0003
BG0016
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00071
BG001163
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint
3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
up to 36 months after the last patient was randomized
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000336
OG001487
Title
Denominators
Categories
Title
Measurements
OG00077.2(71.87 to 82.51)
OG00180.3(73.31 to 87.25)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Cox
0.544
Cox Proportional Hazard
0.95
2-Sided
95
0.80
1.12
Superiority or Other
Secondary
Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)
The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Number
95% Confidence Interval
Percentage of Participants
up to 36 months after the last patient was randomized
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Secondary
Percent Change From Baseline in Brain Volume at Month 36
The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.
Posted
Least Squares Mean
95% Confidence Interval
Percent Change
Baseline to month 36
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
Secondary
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Number
Percentge of Participants
up to 36 months after the last patient was randomized
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000
Secondary
Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.
The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Number
Percentage of Participants
up to 36 months after the last patient was randomized
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000
Secondary
Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36
Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Least Squares Mean
95% Confidence Interval
T2 Lesions per year
Baseline to 36 months
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000
Secondary
Number of Gd-enhancing Lesions at Month 36
Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Least Squares Mean
95% Confidence Interval
Gd-enhanced lesions per patient per scan
Baseline to 36 months
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000
Secondary
Percent Change in Total T2 Lesion Volume From Baseline to Month 36
Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.
Posted
Mean
Standard Deviation
Percent Change
Baseline to month 36
ID
Title
Description
OG000
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG000
Secondary
Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)
The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG002
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Secondary
Change From Baseline in PRIMUS-Activities
The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG002
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Secondary
Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score
Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
Secondary
Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 0.5 mg to 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG002
Secondary
Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)
The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42*100).
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.
Posted
Mean
Standard Deviation
Score on a scale
Baseline, 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 0.5 mg to 0.5 mg
Secondary
Blood Concentrations of Fingolimod and Fingolimod-phosphate
Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.
Venous blood samples were collected for the analysis.
Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)
Posted
Mean
Standard Deviation
ng/ml
Month 3 up to 36 months
ID
Title
Description
OG000
FTY720 1.25 mg to 0.5 mg
Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment
OG001
FTY720 1.25mg to 0.5 mg
fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg
OG002
FTY720 0.5 mg to 0.5 mg
Secondary
Change in MSFC Z-score and Subscale Scores From Baseline to Month 36
The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.
Full analysis set (FAS) - The main efficacy analyses were performed using the FAS
Posted
Mean
Standard Deviation
Z-scores
Baseline to Month 36
ID
Title
Description
OG000
FTY720 0.5 mg
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG001
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Core: FTY720 1.25 mg
Patients who received FTY720 1.25 mg during core
38
147
132
147
EG001
Core: FTY720 0.5 mg
Patients who received FTY720 0.5 mg during core
84
336
278
336
EG002
Core: Placebo
Patients who received Placebo during core
117
487
406
487
EG003
Extension: FTY1.25-0.5
Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension
7
74
43
74
EG004
Extension: FTY0.5-0.5
Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension
10
196
70
196
EG005
Extension: Placebo-FTY0.5
Patients who received Placebo in core and received 0.5 mg of FTY during Extension
37
301
138
301
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia macrocytic
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG0030 affected74 at risk
EG0040 affected196 at risk
EG0051 affected301 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Atrioventricular block first degree
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Atrioventricular block second degree
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0012 affected336 at risk
EG0020 affected487 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Sinus bradycardia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Tachycardia paroxysmal
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Amblyopia strabismic
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Angle closure glaucoma
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Cataract cortical
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Chorioretinopathy
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Diplopia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Intraocular haematoma
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Macular oedema
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0014 affected336 at risk
EG0024 affected487 at risk
EG003
Myopia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Optic atrophy
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Retinal tear
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Anal polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0012 affected336 at risk
EG0021 affected487 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Asthenia
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Chest discomfort
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Device dislocation
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Device occlusion
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Drug ineffective
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Gait disturbance
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
General physical health deterioration
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0023 affected487 at risk
EG003
Cholelithiasis obstructive
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Blister infected
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Bronchitis viral
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Cystitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Dengue fever
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0012 affected336 at risk
EG0021 affected487 at risk
EG003
H1N1 influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0012 affected336 at risk
EG0021 affected487 at risk
EG003
Herpes zoster infection neurological
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Herpes zoster meningomyelitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Incision site infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0013 affected336 at risk
EG0020 affected487 at risk
EG003
Meningitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Myelitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Ophthalmic herpes simplex
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0014 affected336 at risk
EG0022 affected487 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0023 affected487 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Septic shock
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Serratia sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Systemic mycosis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Tracheobronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0018 affected336 at risk
EG00212 affected487 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Viral infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0003 affected147 at risk
EG0011 affected336 at risk
EG0023 affected487 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0023 affected487 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Fracture displacement
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Limb traumatic amputation
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pneumothorax traumatic
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Skull fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Traumatic renal injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Blood pressure increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Foetal heart rate abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
International normalised ratio decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Troponin increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Weight decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0022 affected487 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0022 affected487 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Bone swelling
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Mobility decreased
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Sjogren's syndrome
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG00111 affected336 at risk
EG0029 affected487 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Dysplastic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Fibrous histiocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Invasive lobular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Medullary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Metastases to kidney
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Non-Hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Osteoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Ovarian cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0016 affected336 at risk
EG0021 affected487 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Arachnoiditis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Central nervous system lesion
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Monoparesis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0013 affected336 at risk
EG0025 affected487 at risk
EG003
Multiple sclerosis relapse
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0025 affected487 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Myelitis transverse
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Nystagmus
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Peroneal nerve palsy
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Primary progressive multiple sclerosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Progressive multiple sclerosis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Quadriparesis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Seizure
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Uhthoff's phenomenon
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0002 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Adjustment disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0022 affected487 at risk
EG003
Depressive symptom
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Mania
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0021 affected487 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0022 affected487 at risk
EG003
Bladder neck sclerosis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Nephrogenic diabetes insipidus
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0012 affected336 at risk
EG0021 affected487 at risk
EG003
Neurogenic bladder
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Urethral obstruction
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0012 affected336 at risk
EG0020 affected487 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Adnexal torsion
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0022 affected487 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Prostatomegaly
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Bronchopneumopathy
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0012 affected336 at risk
EG0020 affected487 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Respiratory arrest
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Jessner's lymphocytic infiltration
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Lentigo
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Activities of daily living impaired
Social circumstances
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Poor personal hygiene
Social circumstances
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Arterial spasm
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Femoral artery occlusion
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0001 affected147 at risk
EG0010 affected336 at risk
EG0020 affected487 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0014 affected336 at risk
EG0022 affected487 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0011 affected336 at risk
EG0020 affected487 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0000 affected147 at risk
EG0010 affected336 at risk
EG0021 affected487 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG00013 affected147 at risk
EG00119 affected336 at risk
EG0020 affected487 at risk
EG0034 affected74 at risk
EG0047 affected196 at risk
EG00511 affected301 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 affected147 at risk
EG00117 affected336 at risk
EG00212 affected487 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00127 affected336 at risk
EG00235 affected487 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00013 affected147 at risk
EG00115 affected336 at risk
EG00218 affected487 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00014 affected147 at risk
EG00121 affected336 at risk
EG00219 affected487 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG00016 affected147 at risk
EG00124 affected336 at risk
EG00243 affected487 at risk
EG003
Gait disturbance
General disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00115 affected336 at risk
EG00224 affected487 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00118 affected336 at risk
EG00220 affected487 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00116 affected336 at risk
EG00221 affected487 at risk
EG003
Cystitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG0019 affected336 at risk
EG00217 affected487 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00112 affected336 at risk
EG00222 affected487 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00014 affected147 at risk
EG00126 affected336 at risk
EG00243 affected487 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00040 affected147 at risk
EG00178 affected336 at risk
EG002135 affected487 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00021 affected147 at risk
EG00137 affected336 at risk
EG00257 affected487 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00021 affected147 at risk
EG00147 affected336 at risk
EG00275 affected487 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG00031 affected147 at risk
EG00147 affected336 at risk
EG00291 affected487 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG00017 affected147 at risk
EG00139 affected336 at risk
EG0027 affected487 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00115 affected336 at risk
EG00216 affected487 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG00019 affected147 at risk
EG00131 affected336 at risk
EG0023 affected487 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00113 affected336 at risk
EG00219 affected487 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00013 affected147 at risk
EG00130 affected336 at risk
EG00248 affected487 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG00016 affected147 at risk
EG00136 affected336 at risk
EG00275 affected487 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0009 affected147 at risk
EG00121 affected336 at risk
EG00235 affected487 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00021 affected147 at risk
EG00116 affected336 at risk
EG00231 affected487 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00112 affected336 at risk
EG00214 affected487 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00010 affected147 at risk
EG00119 affected336 at risk
EG00229 affected487 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG00028 affected147 at risk
EG00156 affected336 at risk
EG00277 affected487 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG00011 affected147 at risk
EG00115 affected336 at risk
EG00237 affected487 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00112 affected336 at risk
EG00229 affected487 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00128 affected336 at risk
EG00234 affected487 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00114 affected336 at risk
EG00216 affected487 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0008 affected147 at risk
EG00115 affected336 at risk
EG00219 affected487 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG00023 affected147 at risk
EG00143 affected336 at risk
EG00228 affected487 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
trialandresults.registries@novartis.com
ID
Term
D020528
Multiple Sclerosis, Chronic Progressive
Ancestor Terms
ID
Term
D009103
Multiple Sclerosis
D020278
Demyelinating Autoimmune Diseases, CNS
D020274
Autoimmune Diseases of the Nervous System
D009422
Nervous System Diseases
D003711
Demyelinating Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068876
Fingolimod Hydrochloride
Ancestor Terms
ID
Term
D013110
Sphingosine
D000605
Amino Alcohols
D000438
Alcohols
D009930
Organic Chemicals
D011409
Propylene Glycols
D006018
Glycols
D000588
Amines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0010 subjects
FG0021 subjects
Abnormal lab values
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0024 subjects
Withdrawal by Subject
FG0004 subjects
FG0015 subjects
FG0023 subjects
Adverse Event
FG0001 subjects
FG0011 subjects
FG00215 subjects
48.5
± 8.42
4
BG00313
31 to 40
Title
Measurements
BG00022
BG00160
BG00290
BG003172
41 to 50
Title
Measurements
BG00068
BG001127
BG002194
BG003389
>50
Title
Measurements
BG00054
BG001143
BG002199
BG003396
235
BG003469
Male
BG00076
BG001173
BG002252
BG003501
Counts
Participants
OG000336
OG001487
Title
Denominators
Categories
Title
Measurements
OG00054.3(47.16 to 61.45)
OG00158.7(53.30 to 64.18)
OG000293
OG001421
Title
Denominators
Categories
Title
Measurements
OG000-1.49(-1.64 to -1.35)
OG001-1.53(-1.65 to -1.41)
147
OG001133
Title
Denominators
Categories
Title
Measurements
OG00025.0
OG00124.9
147
OG001133
Title
Denominators
Categories
Title
Measurements
OG00054.8
OG00156.7
298
OG001421
Title
Denominators
Categories
Title
Measurements
OG0000.13(0.10 to 0.18)
OG0010.50(0.40 to 0.61)
223
OG001320
Title
Denominators
Categories
Title
Measurements
OG0000.05(0.02 to 0.09)
OG0010.21(0.15 to 0.30)
224
OG001326
Title
Denominators
Categories
Title
Measurements
OG000-9.2± 30.55
OG0018.9± 44.13
Units
Counts
Participants
OG00066
OG001150
OG002230
Title
Denominators
Categories
Title
Measurements
OG0000.2424± 4.18444
OG0010.5921± 4.77704
OG0020.9597± 4.38578
Units
Counts
Participants
OG00068
OG001153
OG002237
Title
Denominators
Categories
Title
Measurements
OG0003.5504± 7.05241
OG0012.6324± 6.22256
OG0022.8830± 6.76499
OG002
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG00070
OG001154
OG002241
Title
Denominators
Categories
Title
Measurements
OG0001.3197± 12.44042
OG0012.8451± 14.04769
OG0023.1394± 12.20929
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG00099
OG001213
OG002320
Title
Denominators
Categories
Title
Measurements
OG000-0.0332± 0.19420
OG001-0.0475± 0.26099
OG002-0.0539± 0.22383
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
OG002
Placebo
Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization
Units
Counts
Participants
OG00075
OG001182
OG002261
Title
Denominators
Categories
Title
Measurements
OG0006.4444± 23.81568
OG0015.5616± 24.59030
OG0029.5899± 23.98316
Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)
Units
Counts
Participants
OG000102
OG001102
OG002249
Title
Denominators
Categories
Month 3 Fingolimod (n=64, 179)
Title
Measurements
OG0006.04± 3.11
OG001NA± NANo evaluable blood concentration available
OG0022.58± 1.34
Month 12 Fingolimod (n=23, 161)
Title
Measurements
OG0006.24± 2.21
OG0012.87± 1.70
OG0022.55± 1.37
Month 18 Fingolimod (n=71,155)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0012.44± 1.15
OG0022.59± 1.44
Month 24 Fingolimod (n=67, 160)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0012.41± 1.30
OG0022.64± 1.50
Month 30 Fingolimod (n=62, 158)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0012.52± 1.28
OG0022.60± 1.33
Month 36 Fingolimod (n=55, 118)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0012.44± 1.08
OG0022.63± 1.38
End of treatment Fingolimod (n=32, 115)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0012.02± 1.10
OG0022.57± 1.51
Month 3 Fingolimod-Phosphate (n=64, 179)
Title
Measurements
OG0003.20± 1.73
OG001NA± NANo evaluable blood concentration available
OG0021.40± 0.747
Month 12 Fingolimod-Phosphate (n=23, 161)
Title
Measurements
OG0003.21± 1.16
OG0011.54± 0.871
OG0021.43± 0.805
Month 18 Fingolimod-Phosphate (n=71,155)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0011.34± 0.630
OG0021.41± 0.758
Month 24 Fingolimod-Phosphate (n=67, 160)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0011.35± 0.765
OG0021.44± 0.790
Month 30 Fingolimod-Phosphate (n=62, 158)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0011.32± 0.676
OG0021.48± 0.759
Month 36 Fingolimod-Phosphate (n=55, 118)
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available
OG0011.32± 0.591
OG0021.51± 0.765
End of treatment Fingolimod-Phosphate (n=32, 115
Title
Measurements
OG000NA± NAPatients switched to 0.5mg. No evaluable blood concentration available