Trial Outcomes & Findings for A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod (NCT NCT03257358)
NCT ID: NCT03257358
Last Updated: 2021-10-07
Results Overview
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
382 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2021-10-07
Participant Flow
165 patients were enrolled but only 163 were treated and included in the Safety Set
Participant milestones
| Measure |
Cohort 1
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
217
|
|
Overall Study
Never Received Treatment
|
2
|
0
|
|
Overall Study
COMPLETED
|
94
|
183
|
|
Overall Study
NOT COMPLETED
|
71
|
34
|
Reasons for withdrawal
| Measure |
Cohort 1
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Overall Study
Adverse Event
|
25
|
12
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
12
|
4
|
|
Overall Study
Non-compliance with fingolimod treatment
|
4
|
2
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Technical problems
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
Withdrawal of informed consent
|
9
|
5
|
|
Overall Study
New therapy for study indication
|
1
|
0
|
|
Overall Study
No longer requires treatment
|
0
|
1
|
Baseline Characteristics
Missing data for some participants
Baseline characteristics by cohort
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 10.72 • n=163 Participants
|
48.9 years
STANDARD_DEVIATION 9.94 • n=217 Participants
|
45.9 years
STANDARD_DEVIATION 10.86 • n=380 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=163 Participants
|
158 Participants
n=217 Participants
|
285 Participants
n=380 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=163 Participants
|
59 Participants
n=217 Participants
|
95 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
136 Participants
n=163 Participants
|
186 Participants
n=217 Participants
|
322 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Black
|
22 Participants
n=163 Participants
|
22 Participants
n=217 Participants
|
44 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=163 Participants
|
3 Participants
n=217 Participants
|
3 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=163 Participants
|
2 Participants
n=217 Participants
|
3 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=163 Participants
|
1 Participants
n=217 Participants
|
4 Participants
n=380 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=163 Participants
|
3 Participants
n=217 Participants
|
4 Participants
n=380 Participants
|
|
Time from Multiple Sclerosis Diagnosis until study treamtent
|
6.78 years
STANDARD_DEVIATION 7.984 • n=163 Participants
|
12.94 years
STANDARD_DEVIATION 7.007 • n=217 Participants
|
10.30 years
STANDARD_DEVIATION 8.033 • n=380 Participants
|
|
Number of Patients with Relaspses within the last year
Number of patients with at least 1 relapse
|
101 Number of patients with relapse
n=162 Participants • Missing data for some participants
|
32 Number of patients with relapse
n=215 Participants • Missing data for some participants
|
133 Number of patients with relapse
n=377 Participants • Missing data for some participants
|
|
Number of Patients with Relaspses within the last year
Number of patients with no relapse
|
61 Number of patients with relapse
n=162 Participants • Missing data for some participants
|
183 Number of patients with relapse
n=215 Participants • Missing data for some participants
|
244 Number of patients with relapse
n=377 Participants • Missing data for some participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
Baseline (BL) n=147,188
|
404.4 cells/uL
Standard Deviation 273.56
|
3.4 cells/uL
Standard Deviation 20.69
|
|
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
Month 6 n=97,156
|
7.6 cells/uL
Standard Deviation 38.04
|
4.8 cells/uL
Standard Deviation 23.52
|
|
Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
Change from BL to Month 6, n=97,156
|
-411.4 cells/uL
Standard Deviation 273.31
|
0.8 cells/uL
Standard Deviation 25.12
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
374.6 cells/uL
Standard Deviation 216.36
|
16.3 cells/uL
Standard Deviation 45.11
|
|
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Month 6 n=97,156
|
19.6 cells/uL
Standard Deviation 58.77
|
18.3 cells/uL
Standard Deviation 42.89
|
|
Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Change from BL to Month 6, n=97,156
|
-368.9 cells/uL
Standard Deviation 218.40
|
1.1 cells/uL
Standard Deviation 51.29
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
74.3 cells/uL
Standard Deviation 43.56
|
22.8 cells/uL
Standard Deviation 41.21
|
|
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Month 6, n=97,156
|
18.2 cells/uL
Standard Deviation 23.00
|
21.7 cells/uL
Standard Deviation 33.28
|
|
Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Change from BL to Month 6 n=97,156
|
-51.5 cells/uL
Standard Deviation 36.24
|
-2.0 cells/uL
Standard Deviation 31.86
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
Baseline (BL) n=148,211
|
53.8 cells/uL
Standard Deviation 38.29
|
11.1 cells/uL
Standard Deviation 31.90
|
|
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
Month 6 n=104,180
|
7.6 cells/uL
Standard Deviation 15.12
|
11.7 cells/uL
Standard Deviation 33.33
|
|
Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
Change from BL to Month 6 n=104,180
|
-43.6 cells/uL
Standard Deviation 32.51
|
-0.7 cells/uL
Standard Deviation 14.38
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
Baseline (BL) n=148,212
|
35.9 cells/uL
Standard Deviation 30.06
|
1.1 cells/uL
Standard Deviation 4.01
|
|
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
Month 6 n=104,181
|
1.7 cells/uL
Standard Deviation 4.17
|
1.6 cells/uL
Standard Deviation 5.55
|
|
Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
Change from BL to Month 6 n=104,181
|
-36.1 cells/uL
Standard Deviation 32.42
|
0.5 cells/uL
Standard Deviation 5.28
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
Baseline (BL) n=148,212
|
55.5 cells/uL
Standard Deviation 36.60
|
2.4 cells/uL
Standard Deviation 5.96
|
|
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
Month 6 n=104,181
|
3.1 cells/uL
Standard Deviation 8.38
|
2.8 cells/uL
Standard Deviation 6.91
|
|
Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
Change from BL to Month 6 n=104,181
|
-53.2 cells/uL
Standard Deviation 39.01
|
0.5 cells/uL
Standard Deviation 6.77
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
Baseline (BL) n=147,188
|
150.9 cells/uL
Standard Deviation 119.48
|
1.8 cells/uL
Standard Deviation 8.87
|
|
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
Month 6 n=97,156
|
4.2 cells/uL
Standard Deviation 22.00
|
3.3 cells/uL
Standard Deviation 15.84
|
|
Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
Change from BL to Month 6 n=97,156
|
-139.3 cells/uL
Standard Deviation 113.25
|
1.2 cells/uL
Standard Deviation 14.89
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
93.1 cells/uL
Standard Deviation 75.22
|
5.6 cells/uL
Standard Deviation 14.85
|
|
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Month 6 n=97,156
|
5.9 cells/uL
Standard Deviation 16.42
|
6.1 cells/uL
Standard Deviation 12.97
|
|
Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Change from BL to Month 6 n=97,156
|
-85.2 cells/uL
Standard Deviation 67.95
|
0.0 cells/uL
Standard Deviation 15.92
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
108.2 cells/uL
Standard Deviation 93.28
|
63.8 cells/uL
Standard Deviation 115.28
|
|
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Month 6 n=97,156
|
55.4 cells/uL
Standard Deviation 102.88
|
52.6 cells/uL
Standard Deviation 40.76
|
|
Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Change from BL to Month 6 n=97,156
|
-40.6 cells/uL
Standard Deviation 103.03
|
-12.5 cells/uL
Standard Deviation 116.16
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
Change from BL to Month 6 n=101,176
|
-181.4 cells/uL
Standard Deviation 125.71
|
-0.2 cells/uL
Standard Deviation 36.61
|
|
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
Baseline (BL) n=144,212
|
201.1 cells/uL
Standard Deviation 134.16
|
18.1 cells/uL
Standard Deviation 33.79
|
|
Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
Month 6 n=101,176
|
15.0 cells/uL
Standard Deviation 10.50
|
17.8 cells/uL
Standard Deviation 19.99
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
Baseline (BL) n=144,212
|
61.8 cells/uL
Standard Deviation 74.29
|
3.3 cells/uL
Standard Deviation 22.58
|
|
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
Month 6 n=101,176
|
3.8 cells/uL
Standard Deviation 6.24
|
4.0 cells/uL
Standard Deviation 21.18
|
|
Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
Change from BL to Month 6 n=101,176
|
-55.1 cells/uL
Standard Deviation 74.36
|
0.3 cells/uL
Standard Deviation 6.40
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Baseline (BL) n=144,212
|
12.3 cells/uL
Standard Deviation 12.88
|
5.3 cells/uL
Standard Deviation 7.66
|
|
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Change from BL to Month 6 n=101,176
|
-7.4 cells/uL
Standard Deviation 10.64
|
0.9 cells/uL
Standard Deviation 8.15
|
|
Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Month 6 n=101,176
|
4.8 cells/uL
Standard Deviation 3.92
|
6.1 cells/uL
Standard Deviation 5.16
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Monocytes (CD14+)
Month 6 n=105,166
|
384.7 cells/uL
Standard Deviation 148.76
|
379.2 cells/uL
Standard Deviation 131.42
|
|
Change From Baseline to Month 6 in Monocytes (CD14+)
Baseline (BL) n=150,197
|
329.6 cells/uL
Standard Deviation 167.52
|
251.7 cells/uL
Standard Deviation 118.46
|
|
Change From Baseline to Month 6 in Monocytes (CD14+)
Change from BL to Month 6 n=105,166
|
66.1 cells/uL
Standard Deviation 139.24
|
123.1 cells/uL
Standard Deviation 123.85
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Neutrophils (CD16+)
Baseline (BL) n=149,197
|
4041.4 cells/uL
Standard Deviation 1576.73
|
3717.9 cells/uL
Standard Deviation 1552.87
|
|
Change From Baseline to Month 6 in Neutrophils (CD16+)
Month 6 n=105,166
|
3505.4 cells/uL
Standard Deviation 1512.81
|
3312.6 cells/uL
Standard Deviation 1311.04
|
|
Change From Baseline to Month 6 in Neutrophils (CD16+)
Change from BL to Month 6 n=105,166
|
-586.0 cells/uL
Standard Deviation 1463.26
|
-439.6 cells/uL
Standard Deviation 1274.80
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in NK Cells (CD56+)
Baseline (BL) n=149,197
|
166.4 cells/uL
Standard Deviation 98.23
|
181.0 cells/uL
Standard Deviation 113.95
|
|
Change From Baseline to Month 6 in NK Cells (CD56+)
Month 6 n=105,166
|
133.6 cells/uL
Standard Deviation 83.41
|
154.5 cells/uL
Standard Deviation 88.99
|
|
Change From Baseline to Month 6 in NK Cells (CD56+)
Change from BL to Month 6 n=105,166
|
-29.4 cells/uL
Standard Deviation 76.42
|
-28.0 cells/uL
Standard Deviation 81.73
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count
Baseline (BL) n=156,213
|
936.3 cells/uL
Standard Deviation 443.31
|
64.4 cells/uL
Standard Deviation 122.56
|
|
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count
Month 6 n=110,182
|
53.4 cells/uL
Standard Deviation 114.61
|
71.3 cells/uL
Standard Deviation 112.50
|
|
Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count
Change from BL to Month 6 n=110,182
|
-884.1 cells/uL
Standard Deviation 440.65
|
1.4 cells/uL
Standard Deviation 105.17
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count
Baseline (BL) n=157,213
|
49.40 cells/uL
Standard Deviation 10.115
|
11.95 cells/uL
Standard Deviation 12.637
|
|
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count
Month 6 n=111,183
|
11.08 cells/uL
Standard Deviation 9.875
|
12.82 cells/uL
Standard Deviation 13.687
|
|
Change From Baseline to Month 6 in Total CD4+ Differential Cell Count
Change from BL to Month 6 n=111,183
|
-39.09 cells/uL
Standard Deviation 12.052
|
0.32 cells/uL
Standard Deviation 6.119
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count
Baseline (BL) n=156,213
|
419.9 cells/uL
Standard Deviation 257.71
|
124.6 cells/uL
Standard Deviation 213.41
|
|
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count
Month 6 n=110,182
|
120.1 cells/uL
Standard Deviation 148.82
|
116.8 cells/uL
Standard Deviation 101.44
|
|
Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count
Change from BL to Month 6 n=110,182
|
-266.2 cells/uL
Standard Deviation 209.45
|
-13.5 cells/uL
Standard Deviation 205.59
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
Baseline (BL) n=157,213
|
21.86 cells/uL
Standard Deviation 7.852
|
25.25 cells/uL
Standard Deviation 14.406
|
|
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
Month 6 n=111,183
|
25.33 cells/uL
Standard Deviation 14.998
|
24.99 cells/uL
Standard Deviation 13.863
|
|
Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
Change from BL to Month 6
|
4.63 cells/uL
Standard Deviation 11.327
|
-0.39 cells/uL
Standard Deviation 4.528
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count
Baseline (BL) n=151,213
|
259.7 cells/uL
Standard Deviation 167.94
|
21.4 cells/uL
Standard Deviation 45.19
|
|
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count
Month 6 n=106,179
|
19.5 cells/uL
Standard Deviation 15.91
|
21.8 cells/uL
Standard Deviation 34.75
|
|
Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count
Change from BL to Month 6 n=106,179
|
-231.3 cells/uL
Standard Deviation 153.49
|
0.1 cells/uL
Standard Deviation 40.66
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
Baseline (BL) n=152,213
|
13.97 cells/uL
Standard Deviation 7.245
|
4.81 cells/uL
Standard Deviation 5.294
|
|
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
Month 6 n=107,180
|
5.38 cells/uL
Standard Deviation 4.368
|
4.83 cells/uL
Standard Deviation 5.236
|
|
Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
Change from BL to Month 6 n=107,180
|
-8.53 cells/uL
Standard Deviation 6.723
|
0.23 cells/uL
Standard Deviation 3.027
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)
Baseline (BL) n=147,188
|
404.4 cells/uL
Standard Deviation 273.56
|
3.4 cells/uL
Standard Deviation 20.69
|
|
Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)
Change from BL to Month 12 n=82,150
|
-376.3 cells/uL
Standard Deviation 277.23
|
-0.8 cells/uL
Standard Deviation 20.10
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
374.6 cells/uL
Standard Deviation 216.36
|
16.3 cells/uL
Standard Deviation 45.11
|
|
Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Change from BL to Month 12 n=83,150
|
-356.8 cells/uL
Standard Deviation 237.76
|
3.9 cells/uL
Standard Deviation 55.06
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
74.3 cells/uL
Standard Deviation 43.56
|
22.8 cells/uL
Standard Deviation 41.21
|
|
Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Change from BL to Month 12 n=83,150
|
-50.4 cells/uL
Standard Deviation 40.40
|
-3.3 cells/uL
Standard Deviation 30.24
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)
Baseline (BL) n=148,211
|
53.8 cells/uL
Standard Deviation 38.29
|
11.1 cells/uL
Standard Deviation 31.90
|
|
Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)
Change from BL to Month 12 n=88,175
|
-42.3 cells/uL
Standard Deviation 38.9
|
-2.1 cells/uL
Standard Deviation 15.04
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)
Baseline (BL) n=148,212
|
35.9 cells/uL
Standard Deviation 30.06
|
1.1 cells/uL
Standard Deviation 4.01
|
|
Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)
Change from BL to Month 12
|
-36.3 cells/uL
Standard Deviation 34.63
|
0.4 cells/uL
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)
Baseline (BL) n=148,212
|
55.5 cells/uL
Standard Deviation 36.60
|
2.4 cells/uL
Standard Deviation 5.96
|
|
Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)
Change from BL to Month 12 n=88,175
|
-52.1 cells/uL
Standard Deviation 41.20
|
0.5 cells/uL
Standard Deviation 7.70
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)
Baseline (BL) n=147,188
|
150.9 cells/uL
Standard Deviation 119.48
|
1.8 cells/uL
Standard Deviation 8.87
|
|
Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)
Change from BL to Month 12 n=83,150
|
-126.3 cells/uL
Standard Deviation 103.38
|
0.6 cells/uL
Standard Deviation 10.24
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
93.1 cells/uL
Standard Deviation 75.22
|
5.6 cells/uL
Standard Deviation 14.85
|
|
Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
Change from BL to Month 12 n=83,150
|
-86.5 cells/uL
Standard Deviation 75.75
|
0.0 cells/uL
Standard Deviation 16.88
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Baseline (BL) n=147,188
|
108.2 cells/uL
Standard Deviation 93.28
|
63.8 cells/uL
Standard Deviation 115.28
|
|
Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
Change from BL to Month 12 n=83,150
|
-55.9 cells/uL
Standard Deviation 57.48
|
-15.9 cells/uL
Standard Deviation 122.31
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)
Baseline (BL) n=144,212
|
201.11 cells/uL
Standard Deviation 134.16
|
18.1 cells/uL
Standard Deviation 33.79
|
|
Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)
Change from BL to Month 12 n=82,174
|
-177.0 cells/uL
Standard Deviation 114.43
|
-0.5 cells/uL
Standard Deviation 40.72
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)
Baseline (BL) n=144,212
|
61.8 cells/uL
Standard Deviation 74.29
|
3.3 cells/uL
Standard Deviation 22.58
|
|
Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)
Change from BL to Month 12 n=82,174
|
-46.4 cells/uL
Standard Deviation 39.15
|
1.4 cells/uL
Standard Deviation 19.59
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Baseline (BL) n=144,212
|
12.3 cells/uL
Standard Deviation 12.88
|
5.3 cells/uL
Standard Deviation 7.66
|
|
Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
Change from BL to Month 12 n=82,174
|
-7.7 cells/uL
Standard Deviation 11.60
|
0.8 cells/uL
Standard Deviation 8.88
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Monocytes (CD14+)
Baseline (BL) n=150,197
|
329.6 cells/uL
Standard Deviation 167.52
|
251.7 cells/uL
Standard Deviation 118.46
|
|
Change From Baseline to Month 12 in Monocytes (CD14+)
Change from BL to Month 12 n=86,164
|
57.1 cells/uL
Standard Deviation 139.91
|
112.4 cells/uL
Standard Deviation 130.82
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Neutrophils (CD16+)
Baseline (BL) n=149,197
|
4041.4 cells/uL
Standard Deviation 1576.73
|
3717.9 cells/uL
Standard Deviation 1552.87
|
|
Change From Baseline to Month 12 in Neutrophils (CD16+)
Change from BL to Month 12 n=87, 164
|
-815.9 cells/uL
Standard Deviation 1368.23
|
-345.0 cells/uL
Standard Deviation 1253.29
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in NK Cells (CD56+)
Change from BL to Month 12 n=87,164
|
-32.6 cells/uL
Standard Deviation 97.86
|
-28.9 cells/uL
Standard Deviation 86.71
|
|
Change From Baseline to Month 12 in NK Cells (CD56+)
Baseline (BL) n=149,197
|
166.4 cells/uL
Standard Deviation 98.23
|
181.0 cells/uL
Standard Deviation 113.95
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count
Baseline (BL) n=156,213
|
936.3 cells/uL
Standard Deviation 443.31
|
64.4 cells/uL
Standard Deviation 122.56
|
|
Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count
Change from BL to Month 12 n=94,176
|
-844.9 cells/uL
Standard Deviation 439.92
|
0.7 cells/uL
Standard Deviation 101.82
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)
Baseline (BL) n=157,213
|
49.40 cells/uL
Standard Deviation 10.115
|
11.95 cells/uL
Standard Deviation 12.637
|
|
Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)
Change from BL to Month 12 n=95,176
|
-37.90 cells/uL
Standard Deviation 12.756
|
0.70 cells/uL
Standard Deviation 6.127
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count
Baseline (BL) n=156,213
|
419.9 cells/uL
Standard Deviation 257.71
|
124.6 cells/uL
Standard Deviation 213.41
|
|
Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count
Change from BL to Month 12 n=94,176
|
-265.1 cells/uL
Standard Deviation 168.81
|
-11.6 cells/uL
Standard Deviation 216.00
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)
Baseline (BL) n=157,213
|
21.86 cells/uL
Standard Deviation 7.852
|
25.25 cells/uL
Standard Deviation 14.406
|
|
Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)
Change from BL to Month 12 n=95,176
|
4.33 cells/uL
Standard Deviation 11.185
|
0.34 cells/uL
Standard Deviation 5.150
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count
Baseline (BL) n=151,213
|
259.7 cells/uL
Standard Deviation 167.94
|
21.4 cells/uL
Standard Deviation 45.19
|
|
Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count
Change from BL to Month 12 n=88,176
|
-218.9 cells/uL
Standard Deviation 127.69
|
1.0 cells/uL
Standard Deviation 52.35
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)
Baseline (BL) n=152,213
|
13.97 cells/uL
Standard Deviation 7.245
|
4.81 cells/uL
Standard Deviation 5.294
|
|
Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)
Change from BL to Month 12 n=89,176
|
-8.86 cells/uL
Standard Deviation 7.222
|
0.20 cells/uL
Standard Deviation 3.210
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
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.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Multiple Sclerosis (MS) Relapses During Treatment
Number of patients with relapses
|
11 relapses
|
13 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Total number of relapses
|
12 relapses
|
13 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Relapses not requiring steroid use
|
5 relapses
|
5 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Relapses requiring steroid use
|
7 relapses
|
8 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Mild relapse
|
5 relapses
|
8 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Moderate relapse
|
6 relapses
|
5 relapses
|
|
Multiple Sclerosis (MS) Relapses During Treatment
Severe relapse
|
1 relapses
|
0 relapses
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
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.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Patients with ≥ 1 relapses
|
11 Participants
|
13 Participants
|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Patients with relapse who received ≥ 1 steroid
|
7 Participants
|
8 Participants
|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Corticosteroids for systemic use
|
7 Participants
|
8 Participants
|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Methylprednisolone sodium succinate
|
4 Participants
|
4 Participants
|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Methylprednisolone
|
3 Participants
|
2 Participants
|
|
Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
Prednisone
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline in Patient Determined Disease Steps (PDDS)
Baseline (BL) n=163,217
|
1.7 scores
Standard Deviation 1.85
|
1.8 scores
Standard Deviation 1.90
|
|
Change From Baseline in Patient Determined Disease Steps (PDDS)
Month 12 n=103,188
|
1.8 scores
Standard Deviation 1.95
|
1.8 scores
Standard Deviation 2.02
|
|
Change From Baseline in Patient Determined Disease Steps (PDDS)
Change from BL to Month 12 n=103,188
|
-0.1 scores
Standard Deviation 0.87
|
-0.0 scores
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline in T2 Lesion Burden
Baseline (BL) n=91,84
|
8.1 number of lesions
Standard Deviation 12.74
|
9.7 number of lesions
Standard Deviation 15.47
|
|
Change From Baseline in T2 Lesion Burden
Month 12 n=21,17
|
6.5 number of lesions
Standard Deviation 8.20
|
13.1 number of lesions
Standard Deviation 13.22
|
|
Change From Baseline in T2 Lesion Burden
Change from BL to Month 12 n=21,17
|
-0.8 number of lesions
Standard Deviation 2.36
|
3.2 number of lesions
Standard Deviation 12.46
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Safety analysis set
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline for New Gd-Enhancing T1 Lesion Count
Month 12 n=33,28
|
0.1 number of lesions
Standard Deviation 0.24
|
0.2 number of lesions
Standard Deviation 0.83
|
|
Change From Baseline for New Gd-Enhancing T1 Lesion Count
Baseline (BL) n=125,147
|
0.4 number of lesions
Standard Deviation 1.09
|
0.2 number of lesions
Standard Deviation 1.21
|
|
Change From Baseline for New Gd-Enhancing T1 Lesion Count
Change from BL to Month 12 n=33,28
|
-0.2 number of lesions
Standard Deviation 0.61
|
0.2 number of lesions
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: Baseline to Month 6 and 12Population: Safety analysis set
Outcome measures
| Measure |
Cohort 1
n=163 Participants
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 Participants
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
Baseline (BL) n=159,215
|
1.273 cells/uL
Standard Deviation 1.2930
|
1.391 cells/uL
Standard Deviation 1.2600
|
|
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
Change from BL to Month 6 n=116,195
|
0.038 cells/uL
Standard Deviation 0.2874
|
0.045 cells/uL
Standard Deviation 0.4724
|
|
Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
Change from BL to Month 12 n=100,180
|
0.040 cells/uL
Standard Deviation 0.3397
|
0.145 cells/uL
Standard Deviation 0.6062
|
Adverse Events
Cohort 1
Serious events: 9 serious events
Other events: 70 other events
Deaths: 0 deaths
Cohort 2
Serious events: 12 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=163 participants at risk
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 participants at risk
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Hyperplasia
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Non-cardiac chest pain
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Appendicitis
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Cellulitis
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Influenza
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia bacterial
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sepsis
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Cohort 1
n=163 participants at risk
RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
|
Cohort 2
n=217 participants at risk
RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.5%
9/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Blepharospasm
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Diplopia
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Eye pain
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Macular oedema
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Photopsia
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Vision blurred
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Eye disorders
Visual impairment
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Chest discomfort
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
4.9%
8/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Gait disturbance
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Acute sinusitis
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Sinusitis
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
8/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
6/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
3.2%
7/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
5.5%
12/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Lymphocyte count decreased
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Transaminases increased
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
2.8%
6/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.5%
9/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.61%
1/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Central nervous system lesion
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Dizziness
|
3.7%
6/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
8.0%
13/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Hypoaesthesia
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Migraine
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.46%
1/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Paraesthesia
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Tremor
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Trigeminal neuralgia
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Anxiety
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.4%
3/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Psychiatric disorders
Depression
|
3.1%
5/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.8%
3/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.92%
2/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypertension
|
2.5%
4/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
1.8%
4/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypotension
|
1.2%
2/163 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
0.00%
0/217 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER