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Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01201356
Recruitment Status : Completed
First Posted : September 14, 2010
Results First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Forms of Multiple Sclerosis
Intervention Drug: Fingolimod
Enrollment 4125
Recruitment Details This was an open-label, multi-center, single treatment arm design allowing patients participating in the fingolimod MS clinical development program to enroll in order to collect additional long-term safety, tolerability, efficacy, and health outcomes data.
Pre-assignment Details This study had two parts: Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data until all Part 1 end of study (EOS) visits and last follow-up visit; Part 2, collecting limited safety and tolerability data, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description Open-label fingolimod 0.5 mg, taken orally once daily
Period Title: Overall Study
Started [1] 4125
Safety Set [2] 4083
Fingolimod Full Analysis Set 4046
Completed 3481
Not Completed 644
Reason Not Completed
Adverse Event             170
Abnormal laboratory value(s)             51
Abnormal test procedure result(s)             3
Unsatisfactory therapeutic effect             112
Condition no longer requires study drug             12
Withdrawal by Subject             144
Lost to Follow-up             50
administrative problems             74
Death             16
Protocol Violation             12
[1]
All enrolled patients
[2]
At least one dose of fingolimod in any study and a post-baseline safety assessment
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Baseline Participants 4125
Hide Baseline Analysis Population Description
Participant Flow and Baseline Characteristics were based on the Enrolled set. Efficacy analyses were based on the Fingolimod Full Analysis Set..
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4125 participants
37.8  (9.05)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4125 participants
< 18 years 1
18 - 30 years 951
31 - 40 years 1497
41 - 55 years 1605
> 55 years 71
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4125 participants
Female
2933
  71.1%
Male
1192
  28.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4125 participants
Caucasian 3927
Black 38
Asian 35
Native American 11
Other 114
1.Primary Outcome
Title Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
Hide Description Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
Time Frame Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4083
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Event (AEs) 2125
Serious Adverse Events (SAEs) 515
Deaths 16
2.Secondary Outcome
Title Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod
Hide Description Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.
Time Frame Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Measure Type: Number
Unit of Measure: Annual number of relapses per patient
Month 0 to Month 6 0.325
Month 0 to Month 12 0.273
Month 0 to Month 24 0.237
Month 0 to Month 36 0.217
Month 0 to Month 48 0.208
Month 0 to Month 60 0.197
Month 0 to Month 72 0.190
Month 0 to Month 84 0.182
Month 0 to Month 96 0.177
Month 0 to Month 108 0.172
Month 0 to Month 120 0.170
Month 0 to Month 132 0.170
Month 0 to Month 144 0.169
Month 0 to Month 156 0.169
Month 0 to end of Study 0.166
Month 0 to end of Follow-up 0.169
3.Secondary Outcome
Title Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod
Hide Description

A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.

In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.

Time Frame Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Measure Type: Number
Unit of Measure: Participants
Month 0 to Month 6 655
Month 0 to Month 12 992
Month 0 to Month 24 1461
Month 0 to Month 36 1794
Month 0 to Month 48 2127
Month 0 to Month 60 2383
Month 0 to Month 72 2616
Month 0 to Month 84 2793
Month 0 to Month 96 2944
Month 0 to Month 108 3036
Month 0 to Month 120 3063
Month 0 to Month 132 3072
Month 0 to Month 144 3075
Month 0 to Month 156 3079
Month 0 to end of Study 2970
Month 0 to end of Follow-up 3079
4.Secondary Outcome
Title Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod
Hide Description Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.
Time Frame Month 0 (Core Baseline) to End of Study (an average of Month 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Measure Type: Number
Unit of Measure: Annual number of T2 lesions per patient
Month 0 to Month 3 Number Analyzed 126 participants
12.324
Month 0 to Month 6 Number Analyzed 785 participants
2.073
Month 0 to Month 12 Number Analyzed 1771 participants
1.360
Month 0 to Month 24 Number Analyzed 1730 participants
1.042
Month 0 to Month 36 Number Analyzed 1514 participants
1.011
Month 0 to Month 48 Number Analyzed 1453 participants
1.008
Month 0 to Month 60 Number Analyzed 1231 participants
0.957
Month 0 to Month 72 Number Analyzed 1270 participants
0.963
Month 0 to Month 84 Number Analyzed 1107 participants
0.906
Month 0 to Month 96 Number Analyzed 578 participants
0.813
Month 0 to Month 108 Number Analyzed 651 participants
0.713
Month 0 to Month 120 Number Analyzed 265 participants
0.702
Month 0 to Month 132 Number Analyzed 52 participants
0.659
Month 0 to Month 144 Number Analyzed 47 participants
0.681
Month 0 to Month 156 Number Analyzed 35 participants
0.637
Month 0 to end of study Number Analyzed 1320 participants
0.751
5.Secondary Outcome
Title Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume
Hide Description Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.
Time Frame Month 3 to End of Study (Study Completion Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Mean (Standard Deviation)
Unit of Measure: mm^3
T2 volume change at Month 3 Number Analyzed 37 participants
-749.5  (5269.04)
T2 volume change at Month 6 Number Analyzed 111 participants
-207.0  (1385.64)
T2 volume change at Month 12 Number Analyzed 1747 participants
-55.0  (1700.16)
T2 volume change at Month 24 Number Analyzed 1591 participants
16.2  (2009.87)
T2 volume change at Month 36 Number Analyzed 1463 participants
235.8  (2519.39)
T2 volume change at Month 48 Number Analyzed 1136 participants
875.1  (4145.99)
T2 volume change at Month 60 Number Analyzed 1181 participants
1546.3  (4556.51)
T2 volume change at Month 72 Number Analyzed 1273 participants
1719.2  (5184.27)
T2 volume change at Month 84 Number Analyzed 1053 participants
1635.8  (5075.13)
T2 volume change at Month 96 Number Analyzed 569 participants
1303.9  (4712.78)
T2 volume change at Month 108 Number Analyzed 648 participants
1562.0  (4654.67)
T2 volume change at Month 120 Number Analyzed 261 participants
1393.1  (4908.76)
T2 volume change at Month 132 Number Analyzed 50 participants
905.9  (3960.94)
T2 volume change at Month 144 Number Analyzed 44 participants
702.7  (3765.80)
T2 volume change at Month 156 Number Analyzed 35 participants
274.0  (5784.85)
T2 volume change at End of Study Number Analyzed 1314 participants
1588.5  (5157.00)
6.Secondary Outcome
Title Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume
Hide Description T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.
Time Frame Month 3 to End of Study (Study Completion Visit)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Mean (Standard Deviation)
Unit of Measure: mm^3
T1 volume change at Month 3 Number Analyzed 12 participants
-519.8  (1339.62)
T1 volume change at Month 12 Number Analyzed 988 participants
49.1  (718.77)
T1 volume change at Month 24 Number Analyzed 1490 participants
64.1  (786.02)
T1 volume change at Month 36 Number Analyzed 1348 participants
151.08  (1001.28)
T1 volume change at Month 48 Number Analyzed 1023 participants
524.8  (1706.26)
T1 volume change at Month 60 Number Analyzed 1068 participants
853.6  (1957.74)
T1 volume change at Month 72 Number Analyzed 1175 participants
975.7  (2637.67)
T1 volume change at Month 84 Number Analyzed 1012 participants
930.1  (2471.70)
T1 volume change at Month 96 Number Analyzed 533 participants
753.4  (1845.63)
T1 volume change at Month 108 Number Analyzed 554 participants
628.7  (1922.45)
T1 volume change at Month 120 Number Analyzed 172 participants
817.3  (2198.58)
T1 volume change at Month 132 Number Analyzed 1 participants
726.7 [1]   (NA)
T1 volume change at End of Study Number Analyzed 1236 participants
800.6  (2247.27)
[1]
NA: Not estimable due to insufficient number of participants with events
7.Secondary Outcome
Title Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod
Hide Description Descriptive statistics on normalized brain volume at core baseline and percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.
Time Frame Month 0 (Core Baseline) to End of Study (an average of Month 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Mean (Standard Deviation)
Unit of Measure: cc
Normalized brain volume at Core Baseline Number Analyzed 1708 participants
1519.63  (81.193)
Percent volume change at Month 3 Number Analyzed 19 participants
-0.19  (0.660)
Percent volume change at Month 6 Number Analyzed 758 participants
-0.20  (0.801)
Percent volume change at Month 12 Number Analyzed 1720 participants
-0.36  (0.901)
Percent volume change at Month 24 Number Analyzed 1699 participants
-0.74  (1.209)
Percent volume change at Month 36 Number Analyzed 1480 participants
-1.03  (1.541)
Percent volume change at Month 48 Number Analyzed 1414 participants
-1.44  (1.851)
Percent volume change at Month 60 Number Analyzed 1113 participants
-1.65  (2.196)
Percent volume change at Month 72 Number Analyzed 1151 participants
-2.02  (2.514)
Percent volume change at Month 84 Number Analyzed 950 participants
-2.38  (2.638)
Percent volume change at Month 96 Number Analyzed 511 participants
-2.41  (2.607)
Percent volume change at Month 108 Number Analyzed 593 participants
-2.91  (2.863)
Percent volume change at Month 120 Number Analyzed 238 participants
-3.42  (2.911)
Percent volume change at Month 132 Number Analyzed 48 participants
-4.61  (2.511)
Percent volume change at Month 144 Number Analyzed 45 participants
-4.21  (2.778)
Percent volume change at Month 156 Number Analyzed 35 participants
-4.33  (3.146)
8.Secondary Outcome
Title Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod
Hide Description The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = [(SIENA/100+1) ^ (365.25/#days)-1]*100 where SIENA=(Vk/V0-1)*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.
Time Frame Month 3 to Month 156
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Mean (Standard Deviation)
Unit of Measure: Ratio
Month 3 Number Analyzed 19 participants
-0.73  (2.834)
Month 6 Number Analyzed 758 participants
-0.39  (1.590)
Month 12 Number Analyzed 1720 participants
-0.35  (0.891)
Month 24 Number Analyzed 1699 participants
-0.37  (0.615)
Month 36 Number Analyzed 1480 participants
-0.35  (0.522)
Month 48 Number Analyzed 1414 participants
-0.37  (0.480)
Month 60 Number Analyzed 1113 participants
-0.34  (0.451)
Month 72 Number Analyzed 1151 participants
-0.35  (0.433)
Month 84 Number Analyzed 950 participants
-0.35  (0.395)
Month 96 Number Analyzed 511 participants
-0.31  (0.340)
Month 108 Number Analyzed 593 participants
-0.33  (0.326)
Month 120 Number Analyzed 238 participants
-0.36  (0.308)
Month 132 Number Analyzed 48 participants
-0.43  (0.240)
Month 144 Number Analyzed 45 participants
-0.36  (0.244)
Month 156 Number Analyzed 35 participants
-0.35  (0.256)
9.Secondary Outcome
Title Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod
Hide Description Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of >=1 and <=5.5, and by 0.5 points for patients with an FDF baseline EDSS>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.
Time Frame Month 12 to Month 156
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Measure Type: Number
Unit of Measure: Participants
Month 12 212
Month 24 336
Month 36 434
Month 48 519
Month 60 590
Month 72 659
Month 84 714
Month 96 753
Month 108 767
Month 120 772
Month 132 775
Month 144 776
Month 156 777
10.Secondary Outcome
Title Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score
Hide Description

The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (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 overall score is categorized as Improvement, Stable or Deterioration.

If baseline EDSS score is <=5, improvement is indicated by an EDSS score change of <= -1, stable is indicated by an EDSS score change of > -1 and <= 0.5, deterioration is indicated by an EDSS score change of > 0.5; if baseline EDSS score is > 5, improvement is indicated by an EDSS score change of <= -0.5, stable is indicated by an EDSS score change of > -0.5 and <= 0, deterioration is indicated by an EDSS score change of > 0. Only descriptive analysis performed.

Time Frame Month 3 to Month 6 Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Measure Type: Count of Participants
Unit of Measure: Participants
Month 3 Number Analyzed 3769 participants
Improvement 374
Stable 3126
Deterioration 269
Month 6 Number Analyzed 3748 participants
Improvement 508
Stable 2900
Deterioration 340
Month 9 Number Analyzed 3211 participants
Improvement 482
Stable 2425
Deterioration 304
Month 12 Number Analyzed 2674 participants
Improvement 422
Stable 1930
Deterioration 322
Month 15 Number Analyzed 2454 participants
Improvement 405
Stable 1764
Deterioration 285
Month 18 Number Analyzed 1977 participants
Improvement 345
Stable 1361
Deterioration 271
Month 21 Number Analyzed 2187 participants
Improvement 376
Stable 1524
Deterioration 287
Month 24 Number Analyzed 1913 participants
Improvement 320
Stable 1299
Deterioration 294
Month 27 Number Analyzed 1854 participants
Improvement 313
Stable 1271
Deterioration 270
Month 30 Number Analyzed 1796 participants
Improvement 305
Stable 1204
Deterioration 287
Month 33 Number Analyzed 1790 participants
Improvement 326
Stable 1172
Deterioration 292
Month 36 Number Analyzed 1662 participants
Improvement 309
Stable 1065
Deterioration 288
Month 39 Number Analyzed 1575 participants
Improvement 284
Stable 1015
Deterioration 276
Month 42 Number Analyzed 1517 participants
Improvement 282
Stable 948
Deterioration 287
Month 45 Number Analyzed 1382 participants
Improvement 244
Stable 875
Deterioration 263
Month 48 Number Analyzed 1352 participants
Improvement 250
Stable 838
Deterioration 264
Month 51 Number Analyzed 1275 participants
Improvement 244
Stable 784
Deterioration 247
Month 54 Number Analyzed 1295 participants
Improvement 256
Stable 788
Deterioration 251
Month 57 Number Analyzed 1140 participants
Improvement 201
Stable 694
Deterioration 245
Month 60 Number Analyzed 986 participants
Improvement 175
Stable 577
Deterioration 234
Month 63 Number Analyzed 913 participants
Improvement 182
Stable 540
Deterioration 191
Month 66 Number Analyzed 880 participants
Improvement 165
Stable 499
Deterioration 216
Month 69 Number Analyzed 852 participants
Improvement 156
Stable 503
Deterioration 193
Month 72 Number Analyzed 789 participants
Improvement 143
Stable 440
Deterioration 206
Month 75 Number Analyzed 794 participants
Improvement 156
Stable 437
Deterioration 201
Month 78 Number Analyzed 760 participants
Improvement 136
Stable 398
Deterioration 226
Month 81 Number Analyzed 823 participants
Improvement 150
Stable 456
Deterioration 217
Month 84 Number Analyzed 746 participants
Improvement 132
Stable 407
Deterioration 207
Month 87 Number Analyzed 824 participants
Improvement 147
Stable 450
Deterioration 227
Month 90 Number Analyzed 737 participants
Improvement 120
Stable 413
Deterioration 204
Month 93 Number Analyzed 716 participants
Improvement 143
Stable 386
Deterioration 187
Month 96 Number Analyzed 678 participants
Improvement 117
Stable 375
Deterioration 186
Month 99 Number Analyzed 594 participants
Improvement 110
Stable 325
Deterioration 159
Month 102 Number Analyzed 531 participants
Improvement 94
Stable 283
Deterioration 154
Month 105 Number Analyzed 495 participants
Improvement 103
Stable 261
Deterioration 131
Month 108 Number Analyzed 512 participants
Improvement 87
Stable 287
Deterioration 138
Month 111 Number Analyzed 373 participants
Improvement 74
Stable 198
Deterioration 101
Month 114 Number Analyzed 305 participants
Improvement 45
Stable 181
Deterioration 79
Month 117 Number Analyzed 177 participants
Improvement 31
Stable 94
Deterioration 52
Month 120 Number Analyzed 149 participants
Improvement 19
Stable 88
Deterioration 42
Month 123 Number Analyzed 66 participants
Improvement 9
Stable 36
Deterioration 21
Month 126 Number Analyzed 85 participants
Improvement 14
Stable 45
Deterioration 26
Month 129 Number Analyzed 36 participants
Improvement 6
Stable 18
Deterioration 12
Month 132 Number Analyzed 68 participants
Improvement 11
Stable 36
Deterioration 21
Month 135 Number Analyzed 36 participants
Improvement 5
Stable 19
Deterioration 12
Month 138 Number Analyzed 67 participants
Improvement 10
Stable 39
Deterioration 18
Month 141 Number Analyzed 36 participants
Improvement 6
Stable 18
Deterioration 12
Month 144 Number Analyzed 56 participants
Improvement 7
Stable 30
Deterioration 19
Month 147 Number Analyzed 42 participants
Improvement 6
Stable 21
Deterioration 15
Month 150 Number Analyzed 44 participants
Improvement 7
Stable 22
Deterioration 15
Month 153 Number Analyzed 32 participants
Improvement 8
Stable 16
Deterioration 8
Month 156 Number Analyzed 17 participants
Improvement 3
Stable 9
Deterioration 5
Month 159 Number Analyzed 9 participants
Improvement 1
Stable 2
Deterioration 6
Month 162 Number Analyzed 2 participants
Improvement 0
Stable 1
Deterioration 1
End of study Number Analyzed 3814 participants
Improvement 610
Stable 2419
Deterioration 785
Month 3 follow-up Number Analyzed 1491 participants
Improvement 203
Stable 907
Deterioration 381
Month 6 follow-up Number Analyzed 228 participants
Improvement 29
Stable 111
Deterioration 88
11.Secondary Outcome
Title Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)
Hide Description The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (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 overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.
Time Frame Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description:
Open-label fingolimod 0.5 mg, taken orally once daily
Overall Number of Participants Analyzed 4046
Mean (Standard Deviation)
Unit of Measure: EDSS Overall score
Baseline (BL) Number Analyzed 4042 participants
2.39  (1.452)
Change from BL at Month 3 Number Analyzed 3769 participants
-0.06  (0.638)
Change from BL at Month 6 Number Analyzed 3748 participants
-0.07  (0.716)
Change from BL at Month 9 Number Analyzed 3211 participants
-0.09  (0.750)
Change from BL at Month 12 Number Analyzed 2674 participants
-0.07  (0.815)
Change from BL at Month 15 Number Analyzed 2454 participants
-0.08  (0.814)
Change from BL at Month 18 Number Analyzed 1977 participants
-0.05  (0.890)
Change from BL at Month 21 Number Analyzed 2187 participants
-0.08  (0.876)
Change from BL at Month 24 Number Analyzed 1913 participants
-0.01  (0.916)
Change from BL at Month 27 Number Analyzed 1854 participants
-0.03  (0.932)
Change from BL at Month 30 Number Analyzed 1796 participants
-0.00  (0.935)
Change from BL at Month 33 Number Analyzed 1790 participants
-0.02  (0.951)
Change from BL at Month 36 Number Analyzed 1662 participants
0.01  (0.997)
Change from BL at Month 39 Number Analyzed 1575 participants
0.02  (0.963)
Change from BL at Month 42 Number Analyzed 1517 participants
0.04  (1.015)
Change from BL at Month 45 Number Analyzed 1382 participants
0.06  (1.006)
Change from BL at Month 48 Number Analyzed 1352 participants
0.06  (1.063)
Change from BL at Month 51 Number Analyzed 1275 participants
0.06  (1.071)
Change from BL at Month 54 Number Analyzed 1295 participants
0.04  (1.120)
Change from BL at Month 57 Number Analyzed 1140 participants
0.09  (1.077)
Change from BL at Month 60 Number Analyzed 986 participants
0.17  (1.144)
Change from BL at Month 63 Number Analyzed 913 participants
0.08  (1.123)
Change from BL at Month 66 Number Analyzed 880 participants
0.15  (1.220)
Change from BL at Month 69 Number Analyzed 852 participants
0.14  (1.116)
Change from BL at Month 72 Number Analyzed 789 participants
0.22  (1.205)
Change from BL at Month 75 Number Analyzed 794 participants
0.13  (1.159)
Change from BL at Month 78 Number Analyzed 760 participants
0.28  (1.259)
Change from BL at Month 81 Number Analyzed 823 participants
0.18  (1.158)
Change from BL at Month 84 Number Analyzed 746 participants
0.25  (1.236)
Change from BL at Month 87 Number Analyzed 824 participants
0.24  (1.206)
Change from BL at Month 90 Number Analyzed 737 participants
0.29  (1.282)
Change from BL at Month 93 Number Analyzed 716 participants
0.18  (1.219)
Change from BL at Month 96 Number Analyzed 678 participants
0.31  (1.355)
Change from BL at Month 99 Number Analyzed 594 participants
0.18  (1.220)
Change from BL at Month 102 Number Analyzed 531 participants
0.30  (1.332)
Change from BL at Month 105 Number Analyzed 495 participants
0.21  (1.320)
Change from BL at Month 108 Number Analyzed 512 participants
0.28  (1.270)
Change from BL at Month 111 Number Analyzed 373 participants
0.24  (1.343)
Change from BL at Month 114 Number Analyzed 305 participants
0.30  (1.258)
Change from BL at Month 117 Number Analyzed 177 participants
0.35  (1.389)
Change from BL at Month 120 Number Analyzed 149 participants
0.40  (1.271)
Change from BL at Month 123 Number Analyzed 66 participants
0.60  (1.302)
Change from BL at Month 126 Number Analyzed 85 participants
0.38  (1.441)
Change from BL at Month 129 Number Analyzed 36 participants
0.40  (1.448)
Change from BL at Month 132 Number Analyzed 68 participants
0.40  (1.450)
Change from BL at Month 135 Number Analyzed 36 participants
0.51  (1.519)
Change from BL at Month 138 Number Analyzed 67 participants
0.42  (1.527)
Change from BL at Month 141 Number Analyzed 36 participants
0.54  (1.509)
Change from BL at Month 144 Number Analyzed 56 participants
0.60  (1.553)
Change from BL at Month 147 Number Analyzed 42 participants
0.67  (1.640)
Change from BL at Month 150 Number Analyzed 44 participants
0.44  (1.483)
Change from BL at Month 153 Number Analyzed 32 participants
0.23  (1.534)
Change from BL at Month 156 Number Analyzed 17 participants
0.26  (1.427)
Change from BL at Month 159 Number Analyzed 9 participants
1.17  (1.369)
Change from BL at Month 162 Number Analyzed 2 participants
0.75  (1.061)
Change from BL at End of study Number Analyzed 3814 participants
0.14  (1.108)
Change from BL at Month 3 follow-up Number Analyzed 1491 participants
0.29  (1.248)
Change from BL at Month 6 follow-up Number Analyzed 228 participants
0.56  (1.487)
Time Frame Adverse events were collected from first dose of study treatment in Study Part I until end of study treatment in Study Part II plus 6 weeks post treatment, up to a maximum duration of 8 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod 0.5 mg/Day
Hide Arm/Group Description Open-label fingolimod 0.5 mg, taken orally once daily
All-Cause Mortality
Fingolimod 0.5 mg/Day
Affected / at Risk (%)
Total   16/4083 (0.39%) 
Hide Serious Adverse Events
Fingolimod 0.5 mg/Day
Affected / at Risk (%)
Total   515/4083 (12.61%) 
Blood and lymphatic system disorders   
Anaemia  1  3/4083 (0.07%) 
Immune thrombocytopenic purpura  1  1/4083 (0.02%) 
Iron deficiency anaemia  1  1/4083 (0.02%) 
Leukopenia  1  1/4083 (0.02%) 
Lymphadenopathy  1  1/4083 (0.02%) 
Lymphopenia  1  1/4083 (0.02%) 
Thrombocytopenia  1  1/4083 (0.02%) 
Cardiac disorders   
Angina pectoris  1  3/4083 (0.07%) 
Atrial fibrillation  1  6/4083 (0.15%) 
Atrioventricular block first degree  1  1/4083 (0.02%) 
Bradycardia  1  1/4083 (0.02%) 
Cardiac arrest  1  1/4083 (0.02%) 
Cardiac failure  1  1/4083 (0.02%) 
Cardio-respiratory arrest  1  1/4083 (0.02%) 
Cardiopulmonary failure  1  1/4083 (0.02%) 
Cardiovascular insufficiency  1  1/4083 (0.02%) 
Cyanosis  1  1/4083 (0.02%) 
Myocardial infarction  1  4/4083 (0.10%) 
Pericarditis  1  1/4083 (0.02%) 
Supraventricular tachycardia  1  1/4083 (0.02%) 
Ventricular extrasystoles  1  1/4083 (0.02%) 
Ventricular tachycardia  1  1/4083 (0.02%) 
Congenital, familial and genetic disorders   
Atrial septal defect  1  3/4083 (0.07%) 
Bicuspid aortic valve  1  1/4083 (0.02%) 
Congenital cytomegalovirus infection  1  1/4083 (0.02%) 
Congenital knee dislocation  1  1/4083 (0.02%) 
Ear and labyrinth disorders   
Vertigo  1  4/4083 (0.10%) 
Endocrine disorders   
Hyperprolactinaemia  1  1/4083 (0.02%) 
Thyroid mass  1  1/4083 (0.02%) 
Eye disorders   
Photophobia  1  1/4083 (0.02%) 
Retinal detachment  1  2/4083 (0.05%) 
Retinal haemorrhage  1  1/4083 (0.02%) 
Retinal vein thrombosis  1  1/4083 (0.02%) 
Gastrointestinal disorders   
Abdominal adhesions  1  1/4083 (0.02%) 
Abdominal hernia  1  2/4083 (0.05%) 
Abdominal pain  1  4/4083 (0.10%) 
Abdominal pain lower  1  2/4083 (0.05%) 
Anal fissure  1  4/4083 (0.10%) 
Barrett's oesophagus  1  1/4083 (0.02%) 
Colitis  1  1/4083 (0.02%) 
Crohn's disease  1  1/4083 (0.02%) 
Diarrhoea  1  1/4083 (0.02%) 
Duodenal ulcer  1  1/4083 (0.02%) 
Duodenal ulcer perforation  1  1/4083 (0.02%) 
Enterocolitis  1  2/4083 (0.05%) 
Flatulence  1  1/4083 (0.02%) 
Food poisoning  1  1/4083 (0.02%) 
Gastric disorder  1  1/4083 (0.02%) 
Gastric ulcer  1  1/4083 (0.02%) 
Gastritis  1  2/4083 (0.05%) 
Gastrooesophageal reflux disease  1  1/4083 (0.02%) 
Haematochezia  1  1/4083 (0.02%) 
Haemorrhoids  1  2/4083 (0.05%) 
Inguinal hernia  1  3/4083 (0.07%) 
Irritable bowel syndrome  1  2/4083 (0.05%) 
Large intestine polyp  1  1/4083 (0.02%) 
Nausea  1  2/4083 (0.05%) 
Proctalgia  1  1/4083 (0.02%) 
Proctitis  1  1/4083 (0.02%) 
Rectal haemorrhage  1  2/4083 (0.05%) 
Rectal polyp  1  1/4083 (0.02%) 
Umbilical hernia  1  1/4083 (0.02%) 
Vomiting  1  3/4083 (0.07%) 
General disorders   
Death  1  2/4083 (0.05%) 
Death neonatal  1  1/4083 (0.02%) 
Fat tissue increased  1  1/4083 (0.02%) 
Fatigue  1  5/4083 (0.12%) 
Gait disturbance  1  2/4083 (0.05%) 
Hernia  1  1/4083 (0.02%) 
Hypothermia  1  2/4083 (0.05%) 
Influenza like illness  1  1/4083 (0.02%) 
Multiple organ dysfunction syndrome  1  1/4083 (0.02%) 
Non-cardiac chest pain  1  2/4083 (0.05%) 
Peripheral swelling  1  1/4083 (0.02%) 
Pyrexia  1  5/4083 (0.12%) 
Vascular stent stenosis  1  1/4083 (0.02%) 
Hepatobiliary disorders   
Biliary colic  1  5/4083 (0.12%) 
Biliary cyst  1  1/4083 (0.02%) 
Biliary dyskinesia  1  1/4083 (0.02%) 
Cholangitis acute  1  1/4083 (0.02%) 
Cholecystitis  1  4/4083 (0.10%) 
Cholecystitis chronic  1  3/4083 (0.07%) 
Cholelithiasis  1  10/4083 (0.24%) 
Drug-induced liver injury  1  2/4083 (0.05%) 
Hepatitis acute  1  1/4083 (0.02%) 
Liver disorder  1  1/4083 (0.02%) 
Immune system disorders   
Haemophagocytic lymphohistiocytosis  1  1/4083 (0.02%) 
Immunodeficiency  1  1/4083 (0.02%) 
Infections and infestations   
Abdominal abscess  1  1/4083 (0.02%) 
Abdominal sepsis  1  1/4083 (0.02%) 
Appendicitis  1  10/4083 (0.24%) 
Appendicitis perforated  1  2/4083 (0.05%) 
Bartholin's abscess  1  1/4083 (0.02%) 
Bronchitis  1  1/4083 (0.02%) 
Cellulitis  1  6/4083 (0.15%) 
Cystitis  1  1/4083 (0.02%) 
Dermatitis infected  1  1/4083 (0.02%) 
Diverticulitis  1  1/4083 (0.02%) 
Epididymitis  1  2/4083 (0.05%) 
Furuncle  1  1/4083 (0.02%) 
Gastroenteritis  1  1/4083 (0.02%) 
Gastroenteritis viral  1  1/4083 (0.02%) 
Gastrointestinal infection  1  1/4083 (0.02%) 
Groin abscess  1  1/4083 (0.02%) 
Helicobacter infection  1  1/4083 (0.02%) 
Hepatitis A  1  1/4083 (0.02%) 
Hepatitis C  1  2/4083 (0.05%) 
Hepatitis E  1  1/4083 (0.02%) 
Herpes simplex encephalitis  1  1/4083 (0.02%) 
Herpes zoster  1  9/4083 (0.22%) 
Herpes zoster infection neurological  1  1/4083 (0.02%) 
Histoplasmosis  1  1/4083 (0.02%) 
Infected dermal cyst  1  2/4083 (0.05%) 
Infection  1  1/4083 (0.02%) 
Influenza  1  2/4083 (0.05%) 
Injection site abscess  1  1/4083 (0.02%) 
Intervertebral discitis  1  1/4083 (0.02%) 
Lower respiratory tract infection  1  1/4083 (0.02%) 
Lung infection  1  1/4083 (0.02%) 
Lymphangitis  1  1/4083 (0.02%) 
Mastoiditis  1  1/4083 (0.02%) 
Meningitis cryptococcal  1  1/4083 (0.02%) 
Meningoencephalitis herpetic  1  1/4083 (0.02%) 
Orchitis  1  2/4083 (0.05%) 
Pelvic inflammatory disease  1  1/4083 (0.02%) 
Peritonsillar abscess  1  1/4083 (0.02%) 
Pilonidal cyst  1  1/4083 (0.02%) 
Pneumonia  1  14/4083 (0.34%) 
Pneumonia bacterial  1  1/4083 (0.02%) 
Pulmonary tuberculosis  1  1/4083 (0.02%) 
Pyelitis  1  1/4083 (0.02%) 
Pyelonephritis  1  2/4083 (0.05%) 
Renal abscess  1  1/4083 (0.02%) 
Respiratory tract infection  1  1/4083 (0.02%) 
Salpingitis  1  1/4083 (0.02%) 
Salpingo-oophoritis  1  1/4083 (0.02%) 
Sepsis  1  1/4083 (0.02%) 
Sinusitis  1  2/4083 (0.05%) 
Spermatic cord funiculitis  1  1/4083 (0.02%) 
Staphylococcal infection  1  2/4083 (0.05%) 
Subcutaneous abscess  1  1/4083 (0.02%) 
Upper respiratory tract infection  1  2/4083 (0.05%) 
Urinary tract infection  1  14/4083 (0.34%) 
Urinary tract infection enterococcal  1  1/4083 (0.02%) 
Urosepsis  1  1/4083 (0.02%) 
Viraemia  1  1/4083 (0.02%) 
Viral diarrhoea  1  1/4083 (0.02%) 
Viral infection  1  2/4083 (0.05%) 
Vulval abscess  1  1/4083 (0.02%) 
Injury, poisoning and procedural complications   
Alcohol poisoning  1  1/4083 (0.02%) 
Ankle fracture  1  6/4083 (0.15%) 
Arthropod bite  1  1/4083 (0.02%) 
Chest injury  1  1/4083 (0.02%) 
Clavicle fracture  1  1/4083 (0.02%) 
Concussion  1  1/4083 (0.02%) 
Craniocerebral injury  1  1/4083 (0.02%) 
Facial bones fracture  1  1/4083 (0.02%) 
Fall  1  1/4083 (0.02%) 
Femoral neck fracture  1  2/4083 (0.05%) 
Femur fracture  1  1/4083 (0.02%) 
Fibula fracture  1  2/4083 (0.05%) 
Foot fracture  1  2/4083 (0.05%) 
Head injury  1  1/4083 (0.02%) 
Hip fracture  1  2/4083 (0.05%) 
Humerus fracture  1  2/4083 (0.05%) 
Joint injury  1  1/4083 (0.02%) 
Kidney contusion  1  1/4083 (0.02%) 
Ligament rupture  1  2/4083 (0.05%) 
Lower limb fracture  1  2/4083 (0.05%) 
Meniscus injury  1  2/4083 (0.05%) 
Multiple injuries  1  1/4083 (0.02%) 
Muscle injury  1  1/4083 (0.02%) 
Near drowning  1  1/4083 (0.02%) 
Patella fracture  1  1/4083 (0.02%) 
Pelvic fracture  1  1/4083 (0.02%) 
Pubis fracture  1  1/4083 (0.02%) 
Radius fracture  1  1/4083 (0.02%) 
Rib fracture  1  2/4083 (0.05%) 
Road traffic accident  1  5/4083 (0.12%) 
Skull fracture  1  1/4083 (0.02%) 
Spinal fracture  1  1/4083 (0.02%) 
Splenic rupture  1  1/4083 (0.02%) 
Tibia fracture  1  4/4083 (0.10%) 
Traumatic haematoma  1  1/4083 (0.02%) 
Traumatic spinal cord compression  1  1/4083 (0.02%) 
Ulna fracture  1  3/4083 (0.07%) 
Ulnar nerve injury  1  1/4083 (0.02%) 
Upper limb fracture  1  1/4083 (0.02%) 
Vaginal laceration  1  1/4083 (0.02%) 
Wrist fracture  1  2/4083 (0.05%) 
Investigations   
Hepatic enzyme increased  1  1/4083 (0.02%) 
Lymphocyte count decreased  1  1/4083 (0.02%) 
Weight decreased  1  2/4083 (0.05%) 
Metabolism and nutrition disorders   
Dehydration  1  2/4083 (0.05%) 
Hyperamylasaemia  1  1/4083 (0.02%) 
Obesity  1  1/4083 (0.02%) 
Musculoskeletal and connective tissue disorders   
Amyotrophy  1  1/4083 (0.02%) 
Arthralgia  1  2/4083 (0.05%) 
Back pain  1  7/4083 (0.17%) 
Bursitis  1  1/4083 (0.02%) 
Chondromalacia  1  1/4083 (0.02%) 
Chondropathy  1  1/4083 (0.02%) 
Compartment syndrome  1  1/4083 (0.02%) 
Foot deformity  1  1/4083 (0.02%) 
Intervertebral disc protrusion  1  8/4083 (0.20%) 
Jaw disorder  1  1/4083 (0.02%) 
Joint instability  1  1/4083 (0.02%) 
Joint swelling  1  1/4083 (0.02%) 
Lateral patellar compression syndrome  1  1/4083 (0.02%) 
Mobility decreased  1  1/4083 (0.02%) 
Muscular weakness  1  3/4083 (0.07%) 
Osteoarthritis  1  6/4083 (0.15%) 
Osteonecrosis  1  2/4083 (0.05%) 
Pain in extremity  1  1/4083 (0.02%) 
Rhabdomyolysis  1  1/4083 (0.02%) 
Rotator cuff syndrome  1  1/4083 (0.02%) 
Spinal column stenosis  1  1/4083 (0.02%) 
Synovial cyst  1  1/4083 (0.02%) 
Torticollis  1  1/4083 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma of colon  1  3/4083 (0.07%) 
B-cell lymphoma  1  1/4083 (0.02%) 
Basal cell carcinoma  1  30/4083 (0.73%) 
Benign hydatidiform mole  1  1/4083 (0.02%) 
Benign neoplasm of thyroid gland  1  1/4083 (0.02%) 
Benign ovarian tumour  1  1/4083 (0.02%) 
Bladder cancer  1  1/4083 (0.02%) 
Bone giant cell tumour  1  1/4083 (0.02%) 
Bowen's disease  1  3/4083 (0.07%) 
Brain neoplasm benign  1  1/4083 (0.02%) 
Breast cancer  1  11/4083 (0.27%) 
Cervix carcinoma  1  1/4083 (0.02%) 
Colon cancer  1  1/4083 (0.02%) 
Colon cancer metastatic  1  1/4083 (0.02%) 
Desmoid tumour  1  1/4083 (0.02%) 
Extranodal marginal zone B-cell lymphoma (MALT type)  1  1/4083 (0.02%) 
Fibroadenoma of breast  1  1/4083 (0.02%) 
Gastrointestinal neoplasm  1  1/4083 (0.02%) 
Intraductal proliferative breast lesion  1  1/4083 (0.02%) 
Invasive lobular breast carcinoma  1  2/4083 (0.05%) 
Laryngeal squamous cell carcinoma  1  1/4083 (0.02%) 
Leiomyoma  1  1/4083 (0.02%) 
Lung adenocarcinoma  1  1/4083 (0.02%) 
Malignant melanoma  1  3/4083 (0.07%) 
Melanocytic naevus  1  1/4083 (0.02%) 
Meningioma  1  1/4083 (0.02%) 
Metastases to lymph nodes  1  1/4083 (0.02%) 
Metastases to spine  1  1/4083 (0.02%) 
Neoplasm  1  1/4083 (0.02%) 
Non-Hodgkin's lymphoma  1  1/4083 (0.02%) 
Ovarian adenoma  1  1/4083 (0.02%) 
Ovarian cancer metastatic  1  1/4083 (0.02%) 
Pancreatic carcinoma  1  1/4083 (0.02%) 
Papilloma  1  1/4083 (0.02%) 
Phyllodes tumour  1  1/4083 (0.02%) 
Prostate cancer  1  3/4083 (0.07%) 
Rectal cancer  1  1/4083 (0.02%) 
Renal cancer  1  3/4083 (0.07%) 
Renal cell carcinoma  1  1/4083 (0.02%) 
Seminoma  1  1/4083 (0.02%) 
Small cell lung cancer  1  1/4083 (0.02%) 
Squamous cell carcinoma  1  9/4083 (0.22%) 
Squamous cell carcinoma of lung  1  1/4083 (0.02%) 
Squamous cell carcinoma of skin  1  3/4083 (0.07%) 
Thyroid adenoma  1  1/4083 (0.02%) 
Uterine cancer  1  1/4083 (0.02%) 
Uterine leiomyoma  1  10/4083 (0.24%) 
Nervous system disorders   
Altered state of consciousness  1  2/4083 (0.05%) 
Brain hypoxia  1  1/4083 (0.02%) 
Carotid artery occlusion  1  1/4083 (0.02%) 
Cauda equina syndrome  1  1/4083 (0.02%) 
Central nervous system lesion  1  1/4083 (0.02%) 
Cerebellar infarction  1  1/4083 (0.02%) 
Cerebral infarction  1  1/4083 (0.02%) 
Cerebral venous thrombosis  1  1/4083 (0.02%) 
Cerebrovascular accident  1  1/4083 (0.02%) 
Coma  1  1/4083 (0.02%) 
Demyelination  1  1/4083 (0.02%) 
Dizziness  1  1/4083 (0.02%) 
Epilepsy  1  8/4083 (0.20%) 
Facial spasm  1  1/4083 (0.02%) 
Fine motor skill dysfunction  1  1/4083 (0.02%) 
Focal dyscognitive seizures  1  1/4083 (0.02%) 
Generalised tonic-clonic seizure  1  1/4083 (0.02%) 
Headache  1  4/4083 (0.10%) 
Hemianopia homonymous  1  1/4083 (0.02%) 
Hemiparesis  1  1/4083 (0.02%) 
Hyperaesthesia  1  1/4083 (0.02%) 
Hypoaesthesia  1  1/4083 (0.02%) 
Intracranial aneurysm  1  1/4083 (0.02%) 
Ischaemic stroke  1  3/4083 (0.07%) 
Lacunar infarction  1  1/4083 (0.02%) 
Loss of consciousness  1  2/4083 (0.05%) 
Migraine  1  2/4083 (0.05%) 
Multiple sclerosis  1  3/4083 (0.07%) 
Multiple sclerosis relapse  1  34/4083 (0.83%) 
Muscle spasticity  1  1/4083 (0.02%) 
Myelitis transverse  1  2/4083 (0.05%) 
Neuralgia  1  2/4083 (0.05%) 
Optic neuritis  1  3/4083 (0.07%) 
Paraesthesia  1  2/4083 (0.05%) 
Partial seizures  1  1/4083 (0.02%) 
Presyncope  1  2/4083 (0.05%) 
Sciatica  1  1/4083 (0.02%) 
Secondary progressive multiple sclerosis  1  2/4083 (0.05%) 
Seizure  1  3/4083 (0.07%) 
Spinal cord compression  1  1/4083 (0.02%) 
Status epilepticus  1  1/4083 (0.02%) 
Subarachnoid haemorrhage  1  3/4083 (0.07%) 
Syncope  1  4/4083 (0.10%) 
Tension headache  1  1/4083 (0.02%) 
Thrombotic stroke  1  1/4083 (0.02%) 
Transient ischaemic attack  1  3/4083 (0.07%) 
Trigeminal neuralgia  1  3/4083 (0.07%) 
Uhthoff's phenomenon  1  1/4083 (0.02%) 
Ulnar nerve palsy  1  1/4083 (0.02%) 
Wernicke's encephalopathy  1  1/4083 (0.02%) 
Pregnancy, puerperium and perinatal conditions   
Abortion  1  1/4083 (0.02%) 
Abortion spontaneous  1  10/4083 (0.24%) 
Ectopic pregnancy  1  1/4083 (0.02%) 
Hyperemesis gravidarum  1  1/4083 (0.02%) 
Product Issues   
Device dislocation  1  1/4083 (0.02%) 
Psychiatric disorders   
Acute stress disorder  1  1/4083 (0.02%) 
Adjustment disorder with depressed mood  1  2/4083 (0.05%) 
Aggression  1  1/4083 (0.02%) 
Anxiety  1  1/4083 (0.02%) 
Bipolar I disorder  1  2/4083 (0.05%) 
Completed suicide  1  3/4083 (0.07%) 
Confusional state  1  2/4083 (0.05%) 
Depression  1  9/4083 (0.22%) 
Drug dependence  1  1/4083 (0.02%) 
Eating disorder  1  1/4083 (0.02%) 
Major depression  1  2/4083 (0.05%) 
Mania  1  3/4083 (0.07%) 
Mental disorder  1  2/4083 (0.05%) 
Panic attack  1  2/4083 (0.05%) 
Persecutory delusion  1  1/4083 (0.02%) 
Personality change  1  1/4083 (0.02%) 
Personality change due to a general medical condition  1  1/4083 (0.02%) 
Psychogenic seizure  1  1/4083 (0.02%) 
Psychotic disorder  1  1/4083 (0.02%) 
Somatic symptom disorder  1  1/4083 (0.02%) 
Stress  1  1/4083 (0.02%) 
Suicidal ideation  1  5/4083 (0.12%) 
Suicide attempt  1  3/4083 (0.07%) 
Renal and urinary disorders   
Acute kidney injury  1  2/4083 (0.05%) 
Calculus urinary  1  1/4083 (0.02%) 
Hydronephrosis  1  1/4083 (0.02%) 
Nephrolithiasis  1  3/4083 (0.07%) 
Renal haemorrhage  1  1/4083 (0.02%) 
Urinary incontinence  1  2/4083 (0.05%) 
Urinary retention  1  2/4083 (0.05%) 
Reproductive system and breast disorders   
Adnexa uteri cyst  1  1/4083 (0.02%) 
Benign prostatic hyperplasia  1  1/4083 (0.02%) 
Breast calcifications  1  1/4083 (0.02%) 
Cervical dysplasia  1  7/4083 (0.17%) 
Dysfunctional uterine bleeding  1  1/4083 (0.02%) 
Endometriosis  1  1/4083 (0.02%) 
Gynaecomastia  1  1/4083 (0.02%) 
Metrorrhagia  1  3/4083 (0.07%) 
Ovarian cyst  1  4/4083 (0.10%) 
Postmenopausal haemorrhage  1  1/4083 (0.02%) 
Uterine cyst  1  1/4083 (0.02%) 
Uterine haemorrhage  1  3/4083 (0.07%) 
Uterine polyp  1  4/4083 (0.10%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  1/4083 (0.02%) 
Aspiration  1  1/4083 (0.02%) 
Asthma  1  1/4083 (0.02%) 
Cough  1  1/4083 (0.02%) 
Dyspnoea  1  1/4083 (0.02%) 
Epistaxis  1  1/4083 (0.02%) 
Haemothorax  1  1/4083 (0.02%) 
Nasal polyps  1  1/4083 (0.02%) 
Pneumothorax  1  1/4083 (0.02%) 
Pulmonary embolism  1  5/4083 (0.12%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  1/4083 (0.02%) 
Dermatitis  1  1/4083 (0.02%) 
Dermatitis contact  1  1/4083 (0.02%) 
Erythema  1  1/4083 (0.02%) 
Erythema annulare  1  1/4083 (0.02%) 
Rash  1  1/4083 (0.02%) 
Skin erosion  1  1/4083 (0.02%) 
Surgical and medical procedures   
Abortion induced  1  1/4083 (0.02%) 
Vascular disorders   
Aneurysm  1  1/4083 (0.02%) 
Aortic aneurysm  1  1/4083 (0.02%) 
Deep vein thrombosis  1  4/4083 (0.10%) 
Hypertension  1  2/4083 (0.05%) 
Hypertensive crisis  1  1/4083 (0.02%) 
Hypoperfusion  1  1/4083 (0.02%) 
Peripheral artery thrombosis  1  1/4083 (0.02%) 
Peripheral venous disease  1  2/4083 (0.05%) 
Phlebitis  1  1/4083 (0.02%) 
Shock haemorrhagic  1  1/4083 (0.02%) 
Vasculitis  1  1/4083 (0.02%) 
Venous stenosis  1  1/4083 (0.02%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod 0.5 mg/Day
Affected / at Risk (%)
Total   2125/4083 (52.05%) 
Blood and lymphatic system disorders   
Lymphopenia  1  219/4083 (5.36%) 
General disorders   
Fatigue  1  232/4083 (5.68%) 
Infections and infestations   
Bronchitis  1  214/4083 (5.24%) 
Influenza  1  275/4083 (6.74%) 
Nasopharyngitis  1  706/4083 (17.29%) 
Upper respiratory tract infection  1  346/4083 (8.47%) 
Urinary tract infection  1  335/4083 (8.20%) 
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  212/4083 (5.19%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  208/4083 (5.09%) 
Back pain  1  279/4083 (6.83%) 
Nervous system disorders   
Headache  1  348/4083 (8.52%) 
Psychiatric disorders   
Depression  1  205/4083 (5.02%) 
Vascular disorders   
Hypertension  1  243/4083 (5.95%) 
1
Term from vocabulary, MedDRA (21.1)
Indicates events were collected by systematic assessment
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 (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01201356    
Other Study ID Numbers: CFTY720D2399
2010-020515-37 ( EudraCT Number )
First Submitted: September 10, 2010
First Posted: September 14, 2010
Results First Submitted: October 15, 2019
Results First Posted: November 7, 2019
Last Update Posted: November 7, 2019