| Primary | Change From Baseline (BL) in Expanded Disability Status Scale (EDSS) | 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. | 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. | Posted | | Least Squares Mean | Standard Error | score on a scale | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.58± 0.154
- OG0011.17± 0.185
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| | 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 |
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| | ANCOVA | | 0.0155 | | Difference in LS Means | -0.59 | | | 2-Sided | 95 | -1.07 | -0.11 | | | | | Superiority or Other | | |
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| Secondary | Number of Participants With Disability Progression | 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. | 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. | Posted | | Number | | Participants | | 10 Years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous: High Efficacy DMTs | 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. | | OG002 | 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. |
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| Secondary | Number of Participants With EDSS <4 or <6 | 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. | 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. | Posted | | Number | | Participants | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous: High Efficacy DMTs | 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. | | OG002 | 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. |
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| Secondary | Number of Participants Not Using a Wheelchair or Being Bedridden | The number of participants not using a wheelchair or being bedridden was assessed. | 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. | Posted | | Number | | Participants | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous: High Efficacy DMTs | 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. | | OG002 | 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. |
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| Secondary | Number of Participants Classified as Secondary Progressive MS (SPMS) | 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. | 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. | Posted | | Number | | Participants | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous: High Efficacy DMTs | 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. | | OG002 | 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. |
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| Secondary | Percentage of Participants With First Use of an Ambulatory Device | 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. | 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. | Posted | | Number | | Percentage of participants | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Percentage of Participants With First Use of a Wheelchair | First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0. | 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. | Posted | | Number | | Percentage of participants | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT) | 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. | 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. | Posted | | Mean | Standard Deviation | seconds | | baseline from core study, CFTY720D2201 (NCT00333138), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score | 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. | 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. | Posted | | Mean | Standard Deviation | Z score | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous |
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| Secondary | Total Volume in T2 Lesion | Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). | 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. | Posted | | Mean | Standard Deviation | mm^3 | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in Total Volume of T2 Lesion | Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement. | 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. | Posted | | Mean | Standard Deviation | mm^3 | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Third Ventricle Diameter | Third ventricle diameter was assessed by MRI. | 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. | Posted | | Mean | Standard Deviation | mm | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Change From Baseline in Third Ventricle Diameter | Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement. | 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. | Posted | | Mean | Standard Deviation | mm | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Percentage Brain Volume Change (PBVC) | PVBC was assessed by MRI. A negative change from baseline indicates improvement. | 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. | Posted | | Mean | Standard Deviation | Percent change | | baseline from core study (CFTY720D2201 (NCT00333138)), 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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| Secondary | Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters | The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r. | 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. | Posted | | Number | | Pearson correlation coeffcient | | 10 years | | | | ID | Title | Description |
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| OG000 | Continuous | Participants had exposure to FTY720 (study drug or commercially) for at least 8 years. | | OG001 | Non-continuous | Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. |
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