Efficacy of Fingolimod in de Novo Patients Versus Fingoli... | NCT01498887

ID	Type	Description	Link
2011-003484-30	EudraCT Number

Label	Type	Description	Intervention Names
Naive or de novo participants	Experimental	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.	Drug: Fingolimod (FTY720)
Previously treated with first-line DMTs participants	Experimental	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.	Drug: Fingolimod (FTY720)

Name	Type	Description	Arm Group Labels	Other Names
Fingolimod (FTY720)	Drug	Hard gelatin capsules containing 0.5 mg of fingolimod.	Naive or de novo participants Previously treated with first-line DMTs participants

Measure	Description	Time Frame
Annual Relapse Rate (ARR)	ARR = 365 days * number of relapses / total days taking the study medication.	12 months

Measure	Description	Time Frame
Time to First Relapse	Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.	first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Change From Baseline in Expanded Disability Status Scale (EDSS) Score

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		East Gosford	New South Wales	2250	Australia
Novartis Investigative Site

ID	Title	Description
FG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
FG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

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

Annual Relapse Rate (ARR)

ARR = 365 days * number of relapses / total days taking the study medication.

The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.

Posted

Mean

Standard Deviation

Relapses per year

12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants	OG000185 OG001135

Title

Denominators

Categories

Title	Measurements
	OG0000.290± 0.7399 OG0010.354± 0.8547

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		Wilcoxon (Mann-Whitney)		0.3118														Superiority or Other

Secondary

Time to First Relapse

Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.

Posted

Median

95% Confidence Interval

months

first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Expanded Disability Status Scale (EDSS) Score

The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.

Participants from the ITT population with both baseline and 12 month values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.

Posted

Mean

Standard Deviation

score on a scale

baseline, 12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants

Secondary

Change From Baseline in Cerebral Volume

Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.

Posted

Mean

95% Confidence Interval

Percent change

baseline, 12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Mild, Moderate or Severe Relapse

The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.

Only participants from the ITT population with severity values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.

Posted

Number

Percentage of participants

12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants

Secondary

Percentage of Relapse-free Participants

Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.

Posted

Number

Percent

12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants	OG000

Secondary

Mean Number of T2 Active Lesions

The mean number of new or enlarged T2 active lesions was assessed by MRI.

Participants from the ITT population with 12 month T2 lesion numbers were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.

Posted

Mean

Standard Deviation

T2 lesions

12 months

ID	Title	Description
OG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
OG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrioventricular block	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Brain oedema	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Epilepsy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Partial seizures	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0010 affected147 at risk EG0023 affected347 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0009 affected200 at risk EG0017 affected147 at risk EG00216 affected347 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Palpitations	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Retinal anomaly congenital	Congenital, familial and genetic disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Amblyopia	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Astigmatism	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Conjunctivitis	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Diplopia	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Dry eye	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Erythema of eyelid	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Eye pain	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Eyelid oedema	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Macular oedema	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Myopia	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Ocular hyperaemia	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Optic atrophy	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pinguecula	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Presbyopia	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Retinal pigment epitheliopathy	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Strabismus	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Vision blurred	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0013 affected147 at risk EG0025 affected347 at risk
Visual impairment	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0012 affected147 at risk EG0024 affected347 at risk
Vitreous floaters	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0011 affected147 at risk EG0024 affected347 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected200 at risk EG0013 affected147 at risk EG0028 affected347 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Dental caries	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Dental cyst	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected200 at risk EG0019 affected147 at risk EG00214 affected347 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Gastritis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0011 affected147 at risk EG0024 affected347 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected200 at risk EG0011 affected147 at risk EG0025 affected347 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0007 affected200 at risk EG0015 affected147 at risk EG00212 affected347 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Oral discomfort	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Oral pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Toothache	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0014 affected147 at risk EG0026 affected347 at risk
Adverse drug reaction	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Chest discomfort	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk
Exercise tolerance decreased	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG00011 affected200 at risk EG0019 affected147 at risk EG00220 affected347 at risk
Gait disturbance	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Influenza like illness	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0015 affected147 at risk EG0026 affected347 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0010 affected147 at risk EG0023 affected347 at risk
Hypersensitivity	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Acute tonsillitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Bacterial vaginosis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Conjunctivitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Conjunctivitis viral	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Cystitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Ear infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Folliculitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Fungal skin infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Gastric infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0009 affected200 at risk EG0016 affected147 at risk EG00215 affected347 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Genital herpes	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Genitourinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Herpes ophthalmic	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Herpes simplex	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Herpes zoster	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Influenza	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0013 affected147 at risk EG0026 affected347 at risk
Laryngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0010 affected147 at risk EG0023 affected347 at risk
Molluscum contagiosum	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00016 affected200 at risk EG0018 affected147 at risk EG00224 affected347 at risk
Onychomycosis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Oral herpes	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0007 affected200 at risk EG0015 affected147 at risk EG00212 affected347 at risk
Paronychia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Periodontitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pertussis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0008 affected200 at risk EG0014 affected147 at risk EG00212 affected347 at risk
Pharyngitis bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0004 affected200 at risk EG0012 affected147 at risk EG0026 affected347 at risk
Rhinitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Sinusitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0012 affected147 at risk EG0025 affected347 at risk
Sinusitis bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Skin infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0013 affected147 at risk EG0023 affected347 at risk
Tinea versicolour	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Tonsillitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0006 affected200 at risk EG0013 affected147 at risk EG0029 affected347 at risk
Tonsillitis bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Tooth abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Tooth infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Tracheobronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00015 affected200 at risk EG00112 affected147 at risk EG00227 affected347 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00015 affected200 at risk EG00115 affected147 at risk EG00230 affected347 at risk
Viral infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0010 affected147 at risk EG0023 affected347 at risk
Viral pharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0015 affected147 at risk EG0027 affected347 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Wound infection bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Accident	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0010 affected147 at risk EG0023 affected347 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Maternal exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Alanine aminotransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0015 affected147 at risk EG0027 affected347 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0015 affected147 at risk EG0025 affected347 at risk
B-lymphocyte count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Blood calcium decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Blood chloride increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Blood cholesterol increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Blood iron decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Blood pressure increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Blood triglycerides increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
CD4 lymphocytes decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
CD8 lymphocytes decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Electrocardiogram T wave abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0013 affected147 at risk EG0023 affected347 at risk
Hepatic enzyme increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Liver function test abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Low density lipoprotein increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Lymphocyte count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Micturition urgency	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
T-lymphocyte count decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Transaminases abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Weight decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Weight increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0014 affected147 at risk EG0027 affected347 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Polydipsia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00012 affected200 at risk EG0014 affected147 at risk EG00216 affected347 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Haemophilic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0013 affected147 at risk EG0023 affected347 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Myokymia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected200 at risk EG0016 affected147 at risk EG00211 affected347 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0012 affected147 at risk EG0024 affected347 at risk
Sjogren's syndrome	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Amnesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Aphonia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Balance disorder	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Burning sensation	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Dizziness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected200 at risk EG0017 affected147 at risk EG00212 affected347 at risk
Dysaesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Epilepsy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Head discomfort	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00017 affected200 at risk EG00117 affected147 at risk EG00234 affected347 at risk
Hemiparesis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hyperreflexia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Hypersomnia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk
Lethargy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Migraine	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0006 affected200 at risk EG0016 affected147 at risk EG00212 affected347 at risk
Migraine with aura	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Migraine without aura	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0011 affected147 at risk EG0023 affected347 at risk
Neuralgia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Neurological symptom	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Optic neuritis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Paraesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0014 affected147 at risk EG0027 affected347 at risk
Partial seizures	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Presyncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Restless legs syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Sciatica	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Sensorimotor disorder	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Sleep paralysis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Somnolence	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0012 affected147 at risk EG0023 affected347 at risk
Syncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Tension headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Typical aura without headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Uhthoff's phenomenon	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Adjustment disorder with mixed anxiety and depressed mood	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Anxiety	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG00011 affected200 at risk EG0016 affected147 at risk EG00217 affected347 at risk
Anxiety disorder	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Bruxism	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Confusional state	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Depressed mood	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0009 affected200 at risk EG0016 affected147 at risk EG00215 affected347 at risk
Dysthymic disorder	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0005 affected200 at risk EG0013 affected147 at risk EG0028 affected347 at risk
Laziness	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Personality disorder	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Dysuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Polyuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Renal colic	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Renal pain	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Urinary retention	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Sexual dysfunction	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0014 affected147 at risk EG0025 affected347 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0011 affected147 at risk EG0024 affected347 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected200 at risk EG0012 affected147 at risk EG0025 affected347 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected200 at risk EG0013 affected147 at risk EG0027 affected347 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Eczema nummular	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0012 affected147 at risk EG0022 affected347 at risk
Hand dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0010 affected147 at risk EG0022 affected347 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0011 affected147 at risk EG0022 affected347 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0004 affected200 at risk EG0010 affected147 at risk EG0024 affected347 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected200 at risk EG0012 affected147 at risk EG0024 affected347 at risk
Skin depigmentation	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Skin hypertrophy	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Solar lentigo	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Skin lesion excision	Surgical and medical procedures	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Tooth extraction	Surgical and medical procedures	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0010 affected147 at risk EG0021 affected347 at risk
Flushing	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected200 at risk EG0011 affected147 at risk EG0021 affected347 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected200 at risk EG0013 affected147 at risk EG0024 affected347 at risk

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting
D009103	Multiple Sclerosis

ID	Term
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

ID	Term
D013110	Sphingosine
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D011409	Propylene Glycols
D006018	Glycols
D000588	Amines

ID	Title	Description
BG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
BG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Naive or de Novo Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.	11	200	143	200
EG001	Previously Treated With First-line DMTs Participants	Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.	4	147	114	147
EG002	All Participants		15	347	257	347