Long-term Follow-up of Fingolimod Phase II Study Patients (ACROSS)

• ClinicalTrials.gov Identifier: NCT02307838
• Recruitment Status: Completed
• First Posted: December 4, 2014
• Results First Posted: March 23, 2017
• Last Update Posted: March 23, 2017
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
• Intervention: Other: Assessments arm
• Enrollment: 177

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	FTY720 5.0 mg	FTY720 1.25 mg	Placebo
Arm/Group Description	In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.	In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.	In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
Period Title: Overall Study
Started	56	64	55
Completed	56	64	55
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Continuous	Non-continuous	Non-continuous: Other DMTs	Total
Arm/Group Description		Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.	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 of all reporting groups
Overall Number of Baseline Participants		104	16	55	175
Baseline Analysis Population Description		For baseline characteristics and analyses, participants were grouped according to FTY720 exposure: Continuous >= 8 years of FTY720 and Non-continuous < 8 years of FTY720. Non-continuous groups were broken down according to the high-efficacy DMTs' exposure. DMTs included natalizumab, mitoxantrone, alemtuzumab, rituximab, cladribine or ocrelizumab.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	104 participants	16 participants	55 participants	175 participants
		37.4 (8.47)	31.9 (9.05)	38.9 (10.49)	37.4 (9.34)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	104 participants	16 participants	55 participants	175 participants
	Female	63 60.6%	13 81.3%	41 74.5%	117 66.9%
	Male	41 39.4%	3 18.8%	14 25.5%	58 33.1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
Description	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.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	71
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	0.58 (0.154)	1.17 (0.185)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Continuous, Non-continuous
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0155
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.11
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Participants With Disability Progression
Description	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.
Time Frame	10 Years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous: High Efficacy DMTs	Non-continuous: Other DMTs
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	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.	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.
Overall Number of Participants Analyzed	104	16	55
Measure Type: Number; Unit of Measure: Participants
	35	8	29

3. Secondary Outcome

Title	Number of Participants With EDSS <4 or <6
Description	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.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous: High Efficacy DMTs	Non-continuous: Other DMTs
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	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.	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.
Overall Number of Participants Analyzed	104	16	55
Measure Type: Number; Unit of Measure: Participants
EDSS <4	78	10	31
EDSS <6	90	13	41

4. Secondary Outcome

Title	Number of Participants Not Using a Wheelchair or Being Bedridden
Description	The number of participants not using a wheelchair or being bedridden was assessed.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous: High Efficacy DMTs	Non-continuous: Other DMTs
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	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.	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.
Overall Number of Participants Analyzed	104	16	55
Measure Type: Number; Unit of Measure: Participants
	99	13	46

5. Secondary Outcome

Title	Number of Participants Classified as Secondary Progressive MS (SPMS)
Description	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.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous: High Efficacy DMTs	Non-continuous: Other DMTs
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	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.	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.
Overall Number of Participants Analyzed	104	16	55
Measure Type: Number; Unit of Measure: Participants
	10	2	14

6. Secondary Outcome

Title	Percentage of Participants With First Use of an Ambulatory Device
Description	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.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	103	69
Measure Type: Number; Unit of Measure: Percentage of participants
	12.4	17.6

7. Secondary Outcome

Title	Percentage of Participants With First Use of a Wheelchair
Description	First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	71
Measure Type: Number; Unit of Measure: Percentage of participants
	4.9	16.9

8. Secondary Outcome

Title	Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
Description	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.
Time Frame	baseline from core study, CFTY720D2201 (NCT00333138), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	71
Mean (Standard Deviation); Unit of Measure: seconds
	2.29 (5.772)	5.06 (14.523)

9. Secondary Outcome

Title	Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
Description	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.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	70
Mean (Standard Deviation); Unit of Measure: score on a scale
	0.54 (8.273)	-5.39 (12.428)

10. Secondary Outcome

Title	Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
Description	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.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	70
Mean (Standard Deviation); Unit of Measure: score on a scale
	1.32 (11.632)	3.89 (16.070)

11. Secondary Outcome

Title	Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
Description	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.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	69
Mean (Standard Deviation); Unit of Measure: Z score
	-0.11 (0.536)	-0.60 (1.297)

12. Secondary Outcome

Title	Total Volume in T2 Lesion
Description	Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	98	54
Mean (Standard Deviation); Unit of Measure: mm^3
	8685.4 (7743.05)	11279.0 (12570.11)

13. Secondary Outcome

Title	Change From Baseline in Total Volume of T2 Lesion
Description	Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	96	53
Mean (Standard Deviation); Unit of Measure: mm^3
	1031.7 (3725.80)	3636.7 (5259.84)

14. Secondary Outcome

Title	Third Ventricle Diameter
Description	Third ventricle diameter was assessed by MRI.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	97	56
Mean (Standard Deviation); Unit of Measure: mm
	5.28 (2.047)	5.57 (2.648)

15. Secondary Outcome

Title	Change From Baseline in Third Ventricle Diameter
Description	Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	95	55
Mean (Standard Deviation); Unit of Measure: mm
	0.80 (0.848)	0.92 (0.784)

16. Secondary Outcome

Title	Percentage Brain Volume Change (PBVC)
Description	PVBC was assessed by MRI. A negative change from baseline indicates improvement.
Time Frame	baseline from core study (CFTY720D2201 (NCT00333138)), 10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	85	48
Mean (Standard Deviation); Unit of Measure: Percent change
	-9.28 (4.412)	-9.87 (2.909)

17. Secondary Outcome

Title	Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters
Description	The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.
Time Frame	10 years

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Continuous	Non-continuous
Arm/Group Description:	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.	Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
Overall Number of Participants Analyzed	104	71
Measure Type: Number; Unit of Measure: Pearson correlation coeffcient
EDSS score at year 10 (n=101,71)	-0.12	-0.09
Time to 1st use of a cane/crutch/walker (n=13,15)	0.35	0.11
Time to first documenting EDSS of >= 6.0 (n=12,11)	0.27	0.00
Time to first use of a wheelchair (n=5,12)	0.57	0.33
Time to first becoming bedridden (n=0,0)	NA [1]	NA [1]
Time to first SPMS classification (n=10,16)	0.38	0.32
Year 10 PASAT-3 score (n=93,56)	-0.14	0.28
Year 10 PASAT-3 score change from BL (n=93,56)	0.01	0.39

[1]

No participants had become bedridden.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Continuous		Non-continuous: High Efficacy DMTs		Non-continuous: Other DMTs
Arm/Group Description	Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.		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.		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.
All-Cause Mortality
	Continuous		Non-continuous: High Efficacy DMTs		Non-continuous: Other DMTs
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events
	Continuous		Non-continuous: High Efficacy DMTs		Non-continuous: Other DMTs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0.00%)		0/16 (0.00%)		0/55 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Continuous		Non-continuous: High Efficacy DMTs		Non-continuous: Other DMTs
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0.00%)		0/16 (0.00%)		1/55 (1.82%)
Nervous system disorders
Multiple sclerosis relapse † 1	0/104 (0.00%)	0	0/16 (0.00%)	0	1/55 (1.82%)	1
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 18.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Study Director
• Organization: Novartis Pharmaceuticals
• Phone: 862-778-8300

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• ClinicalTrials.gov Identifier: NCT02307838
• Other Study ID Numbers: CFTY720D2201E2
• First Submitted: May 14, 2014
• First Posted: December 4, 2014
• Results First Submitted: November 28, 2016
• Results First Posted: March 23, 2017
• Last Update Posted: March 23, 2017