Trial Outcomes & Findings for Long-term Follow-up of Fingolimod Phase II Study Patients (NCT NCT02307838)

NCT ID: NCT02307838

Last Updated: 2017-03-23

Results Overview

EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 177 participants
• Primary outcome timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
• Results posted on: 2017-03-23

Participant Flow

This extension study was a multicenter follow-up study of participants who enrolled in FTY720D2201 (NCT02307838). Although participants in this study did not receive study treatment, the participant flow is based on the treatments receive in FTY720D2201.

A total of 177 participants were enrolled into the study. However, 2 participants were erroneously enrolled into the study because they did not meet the inclusion criteria. Therefore, they were not included in any analyses, and as such, the participant flow is based on 175 participants.

Participant milestones

Measure	FTY720 5.0 mg In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.	FTY720 1.25 mg In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.	Placebo In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
Overall Study STARTED	56	64	55
Overall Study COMPLETED	56	64	55
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Follow-up of Fingolimod Phase II Study Patients

Baseline characteristics by cohort

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=16 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.	Total n=175 Participants Total of all reporting groups
Age, Continuous	37.4 Years STANDARD_DEVIATION 8.47 • n=5 Participants	31.9 Years STANDARD_DEVIATION 9.05 • n=7 Participants	38.9 Years STANDARD_DEVIATION 10.49 • n=5 Participants	37.4 Years STANDARD_DEVIATION 9.34 • n=4 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	13 Participants n=7 Participants	41 Participants n=5 Participants	117 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	3 Participants n=7 Participants	14 Participants n=5 Participants	58 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=71 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)	0.58 score on a scale Standard Error 0.154	1.17 score on a scale Standard Error 0.185	—

SECONDARY outcome

Timeframe: 10 Years

Population: The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=16 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Number of Participants With Disability Progression	35 Participants	8 Participants	29 Participants

SECONDARY outcome

Timeframe: 10 years

Population: The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=16 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Number of Participants With EDSS <4 or <6 EDSS <4	78 Participants	10 Participants	31 Participants
Number of Participants With EDSS <4 or <6 EDSS <6	90 Participants	13 Participants	41 Participants

SECONDARY outcome

Timeframe: 10 years

Population: The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

The number of participants not using a wheelchair or being bedridden was assessed.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=16 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Number of Participants Not Using a Wheelchair or Being Bedridden	99 Participants	13 Participants	46 Participants

SECONDARY outcome

Timeframe: 10 years

Population: The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=16 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Number of Participants Classified as Secondary Progressive MS (SPMS)	10 Participants	2 Participants	14 Participants

SECONDARY outcome

Timeframe: 10 years

Population: The FAS was considered for the analysis. Only participants with evaluable data were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.

Outcome measures

Measure	Continuous n=103 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=69 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Percentage of Participants With First Use of an Ambulatory Device	12.4 Percentage of participants	17.6 Percentage of participants	—

SECONDARY outcome

Timeframe: 10 years

Population: The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=71 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Percentage of Participants With First Use of a Wheelchair	4.9 Percentage of participants	16.9 Percentage of participants	—

SECONDARY outcome

Timeframe: baseline from core study, CFTY720D2201 (NCT00333138), 10 years

Population: The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=71 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)	2.29 seconds Standard Deviation 5.772	5.06 seconds Standard Deviation 14.523	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=70 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score	0.54 score on a scale Standard Deviation 8.273	-5.39 score on a scale Standard Deviation 12.428	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.

The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=70 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score	1.32 score on a scale Standard Deviation 11.632	3.89 score on a scale Standard Deviation 16.070	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for the analysis. Only participants with both baseline measurements for each MSFC component and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions-arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=69 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score	-0.11 Z score Standard Deviation 0.536	-0.60 Z score Standard Deviation 1.297	—

SECONDARY outcome

Timeframe: 10 years

Population: The FAS was considered for the analysis. Only participants with measurements at 10 years were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).

Outcome measures

Measure	Continuous n=98 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=54 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Total Volume in T2 Lesion	8685.4 mm^3 Standard Deviation 7743.05	11279.0 mm^3 Standard Deviation 12570.11	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for the analysis. Only participants from the FAS who had both baseline and 10 years measurements were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=96 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=53 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in Total Volume of T2 Lesion	1031.7 mm^3 Standard Deviation 3725.80	3636.7 mm^3 Standard Deviation 5259.84	—

SECONDARY outcome

Timeframe: 10 years

Population: The FAS was considered for the analysis. Only participants with 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

Third ventricle diameter was assessed by MRI.

Outcome measures

Measure	Continuous n=97 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=56 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Third Ventricle Diameter	5.28 mm Standard Deviation 2.047	5.57 mm Standard Deviation 2.648	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for analysis. Only participants who had both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=95 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=55 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Change From Baseline in Third Ventricle Diameter	0.80 mm Standard Deviation 0.848	0.92 mm Standard Deviation 0.784	—

SECONDARY outcome

Timeframe: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Population: The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

PVBC was assessed by MRI. A negative change from baseline indicates improvement.

Outcome measures

Measure	Continuous n=85 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=48 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Percentage Brain Volume Change (PBVC)	-9.28 Percent change Standard Deviation 4.412	-9.87 Percent change Standard Deviation 2.909	—

SECONDARY outcome

Timeframe: 10 years

Population: The FAS was considered for the analysis. Only participants who had 10 year correlation measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.

The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.

Outcome measures

Measure	Continuous n=104 Participants Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous n=71 Participants Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	Non-continuous: Other DMTs Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Year 10 PASAT-3 score (n=93,56)	-0.14 Pearson correlation coeffcient	0.28 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters EDSS score at year 10 (n=101,71)	-0.12 Pearson correlation coeffcient	-0.09 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Time to 1st use of a cane/crutch/walker (n=13,15)	0.35 Pearson correlation coeffcient	0.11 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Time to first documenting EDSS of >= 6.0 (n=12,11)	0.27 Pearson correlation coeffcient	0.00 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Time to first use of a wheelchair (n=5,12)	0.57 Pearson correlation coeffcient	0.33 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Time to first becoming bedridden (n=0,0)	NA Pearson correlation coeffcient No participants had become bedridden.	NA Pearson correlation coeffcient No participants had become bedridden.	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Time to first SPMS classification (n=10,16)	0.38 Pearson correlation coeffcient	0.32 Pearson correlation coeffcient	—
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters Year 10 PASAT-3 score change from BL (n=93,56)	0.01 Pearson correlation coeffcient	0.39 Pearson correlation coeffcient	—

Adverse Events

Continuous

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-continuous: High Efficacy DMTs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-continuous: Other DMTs

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Continuous n=104 participants at risk Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Non-continuous: High Efficacy DMTs n=16 participants at risk Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years.	Non-continuous: Other DMTs n=55 participants at risk Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/104	0.00% 0/16	1.8% 1/55 • Number of events 1

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER