Efficacy and Safety of FTY720 in Patients With Relapsing... | NCT00333138

ID	Type	Description	Link
CFTY720D2201E1	Other Identifier	Novartis

Label	Type	Description	Intervention Names
Fingolimod (FTY720) 1.25 mg/day	Experimental	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	Drug: FTY720
Placebo/Fingolimod (FTY720)	Placebo Comparator	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	Drug: Placebo
Fingolimod (FTY720) 5.0 mg/day	Experimental	Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 15 to 24 months 1.25mg once daily. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	Drug: FTY720

Name	Type	Description	Arm Group Labels	Other Names
FTY720	Drug	FTY720 capsule was taken orally once a day	Fingolimod (FTY720) 1.25 mg/day Fingolimod (FTY720) 5.0 mg/day

Measure	Description	Time Frame
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)	Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.	Month 6 (Core)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12	Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.	Month 12 (extension)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60	Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.	Month 60 (extension)
Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study	Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days	Last observation (Up to 80 months in average)

Measure	Description	Time Frame
Percentage of Participants Free of T1-weighted Lesions	A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days	Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigational site		Montreal			Canada
Novartis Investigational site

PubMed Identifier	Type	Citation	Retractions
23531349	Derived	Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.
16971719	Derived	Kappos L, Antel J, Comi G, Montalban X, O'Connor P, Polman CH, Haas T, Korn AA, Karlsson G, Radue EW; FTY720 D2201 Study Group. Oral fingolimod (FTY720) for relapsing multiple sclerosis. N Engl J Med. 2006 Sep 14;355(11):1124-40. doi: 10.1056/NEJMoa052643.

ID	Title	Description
FG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

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

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 6 (Core)

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. Number of patients with T1 information recorded at scan were included in the analysis.

Posted

Mean

Standard Deviation

GD- enhanced T1 lesions

Month 6 (Core)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG002	Fingolimod (FTY720) 5.0 mg/Day	Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Units	Counts
Participants	OG00083 OG00190 OG00287

Title

Denominators

Categories

Title	Measurements
	OG0002.3± 4.23 OG0011.4± 5.69 OG0020.4± 0.82

Secondary

Percentage of Participants Free of T1-weighted Lesions

A patient was defined as free of lesions if s/he had zero lesions. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Posted

Number

percentage of participants

Baseline, Months 6 (core), 12, 60 and Last Observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Primary

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 12

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

Posted

Mean

Standard Deviation

GD- enhanced T1 lesions

Month 12 (extension)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG002

Primary

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at Month 60

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis.

Posted

Mean

Standard Deviation

GD- enhanced T1 lesions

Month 60 (extension)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG002

Primary

Mean Number of Gadolinium (Gd)-Enhanced T1-weighted Lesions at End of Study

Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Posted

Mean

Standard Deviation

GD- enhanced T1 lesions

Last observation (Up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Secondary

Percentage of Patients Free of Gd-enhanced T1-weighted and New T2- Weighted Lesions by Visit

A patient was defined as free of lesions if s/he had zero lesions. The sum of all new T2-weighted lesions at Month 1 to last observation was zero (the sum is missing if one of the assessments was missing). New T2 lesions at a specific visit were assessed relative to the previous visit scan. Exception: new T2 lesions at Month 24 were assessed relative to Month 12. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

All randomized patients who received at least 1 dose of study drug during core study were included in the ITT population. The "n" number of patients with T2 and T1 information recorded at scan

Posted

Number

percentage of paticipants

Month 6 and 12, 60, last observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Secondary

Mean Number of New T2-weighted Lesions

New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (Month 1 to end of study) is calculated as the sum of the number of lesions at Months 1 to 6, Month 12, Month 60 and last observation. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. The "n" in each category indicates participants with T2 information recorded at specific timepoints

Posted

Mean

Standard Deviation

GD enhanced T2 lesions

(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Secondary

Volume of T2-weighted Lesions

Volume of total T2-weighted lesions by visit were summarized. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

Posted

Mean

Standard Deviation

mm^3

(Core) Month 6 and (Extension) 12, 60, last observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG002

Secondary

Change From Baseline in Volume of Total T2-weighted Lesions

Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume). The last observation was the last observation available for each patient which ranged from 1 to 2801 days.

Posted

Mean

Standard Deviation

mm^3

Baseline to month 6, 12, 60 and Last observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
OG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Secondary

Time to Event Analysis: Kaplan Meier Estimates of Percentage of Relapse-free Patients

The Expanded Disability Status Scale (EDSS) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method. The last observation was the last observation available for each patient which ranged from 1 to 2801 days

All randomized patients who received at least 1 dose of study drug during the core study were included in the ITT population. A patient at risk are those continuing in the study without an event before the specified timepoint The "n" denotes number of patients at risk.

Posted

Number

95% Confidence Interval

percentage of participants

Month 6,12,60 and Last observation (up to 80 months in average)

ID	Title	Description
OG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.

Secondary

Mean Trough Blood Concentrations of FTY720

For each patient, the arithmetic mean of the two FTY720 trough blood levels from month 3 and 6 was calculated. This was taken as the patient's steady-state trough levels. Venous blood samples (3 mL) were collected before the dose in ethylenediaminetetraacetic acid (EDTA)-containing tubes at protocol-scheduled visits at months 3 and 6 in all patients.

Pharmacokinetics population included all the patients who had sample collected and analysis was performed

Posted

Mean

Standard Deviation

ng/mL

Month 3 and 6

ID	Title	Description
OG000	FTY720 1.25 mg/Day	Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
OG001	FTY720 5.0 mg/Day	Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0023 affected94 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Adrenal mass	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Eye oedema	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Macular oedema	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0012 affected94 at risk EG0022 affected94 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Retinal vein thrombosis	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Vision blurred	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Volvulus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0022 affected94 at risk
Concomitant disease progression	General disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0012 affected94 at risk EG0020 affected94 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Dengue fever	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Salpingitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Drug exposure during pregnancy	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Chest X-ray abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Heart rate abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0022 affected94 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Lentigo maligna stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0012 affected94 at risk EG0020 affected94 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0023 affected94 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Paraparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Reversible posterior leukoencephalopathy syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Status epilepticus	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Abortion	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0012 affected94 at risk EG0020 affected94 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0022 affected94 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Hirsutism	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0011 affected94 at risk EG0020 affected94 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Varicose ulceration	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0010 affected94 at risk EG0020 affected94 at risk
Varicose vein	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 affected93 at risk EG00114 affected94 at risk EG00215 affected94 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00013 affected93 at risk EG00118 affected94 at risk EG00218 affected94 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0011 affected94 at risk EG0023 affected94 at risk
Conjunctivitis	Eye disorders	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0017 affected94 at risk EG0023 affected94 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0015 affected94 at risk EG0027 affected94 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG00110 affected94 at risk EG0028 affected94 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0015 affected94 at risk EG0024 affected94 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected93 at risk EG0014 affected94 at risk EG00212 affected94 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00012 affected93 at risk EG00118 affected94 at risk EG00215 affected94 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG00110 affected94 at risk EG0024 affected94 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0011 affected94 at risk EG0021 affected94 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected93 at risk EG00110 affected94 at risk EG00216 affected94 at risk
Toothache	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0015 affected94 at risk EG0028 affected94 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0016 affected94 at risk EG0026 affected94 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0008 affected93 at risk EG0014 affected94 at risk EG0023 affected94 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0014 affected94 at risk EG0025 affected94 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00022 affected93 at risk EG00123 affected94 at risk EG00216 affected94 at risk
Gait disturbance	General disorders	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0015 affected94 at risk EG0022 affected94 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0015 affected94 at risk EG0025 affected94 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0016 affected94 at risk EG00212 affected94 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0009 affected93 at risk EG00117 affected94 at risk EG00212 affected94 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0012 affected94 at risk EG0026 affected94 at risk
Ear infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0016 affected94 at risk EG0023 affected94 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0018 affected94 at risk EG00214 affected94 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0017 affected94 at risk EG0024 affected94 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG00016 affected93 at risk EG00123 affected94 at risk EG00222 affected94 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00034 affected93 at risk EG00139 affected94 at risk EG00242 affected94 at risk
Oral herpes	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0015 affected94 at risk EG0024 affected94 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected93 at risk EG00111 affected94 at risk EG0025 affected94 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0015 affected94 at risk EG0023 affected94 at risk
Rhinitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0015 affected94 at risk EG0022 affected94 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected93 at risk EG00112 affected94 at risk EG00212 affected94 at risk
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0016 affected94 at risk EG0023 affected94 at risk
Tooth infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0017 affected94 at risk EG0027 affected94 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00019 affected93 at risk EG00119 affected94 at risk EG00218 affected94 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00011 affected93 at risk EG00110 affected94 at risk EG00211 affected94 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0016 affected94 at risk EG0024 affected94 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0015 affected94 at risk EG0024 affected94 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0007 affected93 at risk EG0016 affected94 at risk EG0024 affected94 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0015 affected94 at risk EG0022 affected94 at risk
Alanine aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG00018 affected93 at risk EG00112 affected94 at risk EG00215 affected94 at risk
Aspartate aminotransferase increased	Investigations	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0013 affected94 at risk EG0022 affected94 at risk
Lymphocyte count decreased	Investigations	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0016 affected94 at risk EG0027 affected94 at risk
White blood cell count decreased	Investigations	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0015 affected94 at risk EG0025 affected94 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected93 at risk EG0014 affected94 at risk EG0025 affected94 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0016 affected94 at risk EG0025 affected94 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0012 affected94 at risk EG0024 affected94 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00017 affected93 at risk EG00114 affected94 at risk EG00212 affected94 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00022 affected93 at risk EG00116 affected94 at risk EG00219 affected94 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0014 affected94 at risk EG0028 affected94 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0013 affected94 at risk EG0025 affected94 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0016 affected94 at risk EG0026 affected94 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0013 affected94 at risk EG0025 affected94 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0018 affected94 at risk EG0024 affected94 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00018 affected93 at risk EG00115 affected94 at risk EG00215 affected94 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 affected93 at risk EG0011 affected94 at risk EG0021 affected94 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0015 affected94 at risk EG0025 affected94 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00013 affected93 at risk EG0018 affected94 at risk EG00210 affected94 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00028 affected93 at risk EG00135 affected94 at risk EG00225 affected94 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG00013 affected93 at risk EG0018 affected94 at risk EG0029 affected94 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG00010 affected93 at risk EG0016 affected94 at risk EG0026 affected94 at risk
Muscle spasticity	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0012 affected94 at risk EG0026 affected94 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected93 at risk EG00110 affected94 at risk EG0025 affected94 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0014 affected94 at risk EG0026 affected94 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0015 affected94 at risk EG0022 affected94 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0017 affected94 at risk EG0027 affected94 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG00015 affected93 at risk EG00112 affected94 at risk EG00214 affected94 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG00012 affected93 at risk EG00115 affected94 at risk EG0028 affected94 at risk
Pollakiuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0013 affected94 at risk EG0021 affected94 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected93 at risk EG0019 affected94 at risk EG0021 affected94 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0015 affected94 at risk EG0024 affected94 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected93 at risk EG0011 affected94 at risk EG0026 affected94 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00012 affected93 at risk EG00116 affected94 at risk EG00219 affected94 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0017 affected94 at risk EG00215 affected94 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00010 affected93 at risk EG0016 affected94 at risk EG0029 affected94 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0013 affected94 at risk EG0026 affected94 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0006 affected93 at risk EG0017 affected94 at risk EG0026 affected94 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0003 affected93 at risk EG0016 affected94 at risk EG0026 affected94 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0014 affected94 at risk EG0024 affected94 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0007 affected93 at risk EG0016 affected94 at risk EG0028 affected94 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0005 affected93 at risk EG0010 affected94 at risk EG0021 affected94 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00013 affected93 at risk EG00119 affected94 at risk EG00210 affected94 at risk

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	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
BG001	Fingolimod (FTY720) 1.25 mg/Day	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
BG002	Fingolimod (FTY720) 5.0 mg/Day	Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	25	93	86	93
EG001	Fingolimod (FTY720) 1.25 mg	Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	19	94	88	94
EG002	Fingolimod (FTY720) 5.0 mg	Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.	32	94	92	94