Trial Outcomes & Findings for Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis (NCT NCT00662649)
NCT ID: NCT00662649
Last Updated: 2012-07-12
Results Overview
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
920 participants
Primary outcome timeframe
Months 0 to end of study (maximum up to 60 months)
Results posted on
2012-07-12
Participant Flow
Of the 1272 patients randomly assigned to treatment in the Core study (ClinicalTrials.gov ID NCT00289978), 1033 completed the 24-month double-blind treatment phase and were eligible to enter the Extension study. A total of 920 of the 1033 patients entered the Extension study and received treatment.
Participant milestones
| Measure |
Fingolimod 1.25 mg
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 1.25 mg
Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
|
Placebo-fingolimod 0.5
Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|---|
|
Core Study (24 Months)
STARTED
|
429
|
425
|
418
|
0
|
0
|
|
Core Study (24 Months)
Intent to Treat (ITT)
|
429
|
425
|
418
|
0
|
0
|
|
Core Study (24 Months)
COMPLETED
|
332
|
369
|
332
|
0
|
0
|
|
Core Study (24 Months)
NOT COMPLETED
|
97
|
56
|
86
|
0
|
0
|
|
Extension Study (Month 24 to 60)
STARTED
|
289
|
331
|
0
|
145
|
155
|
|
Extension Study (Month 24 to 60)
Extension Intent to Treat Population
|
287
|
330
|
0
|
145
|
154
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 24
|
289
|
331
|
0
|
145
|
155
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 30
|
276
|
324
|
0
|
136
|
152
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 36
|
270
|
311
|
0
|
130
|
145
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 42
|
254
|
301
|
0
|
120
|
136
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 48
|
125
|
152
|
0
|
58
|
67
|
|
Extension Study (Month 24 to 60)
From Beginning of Core at Month 54
|
31
|
32
|
0
|
11
|
13
|
|
Extension Study (Month 24 to 60)
COMPLETED
|
245
|
290
|
0
|
112
|
126
|
|
Extension Study (Month 24 to 60)
NOT COMPLETED
|
44
|
41
|
0
|
33
|
29
|
Reasons for withdrawal
| Measure |
Fingolimod 1.25 mg
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod(either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 1.25 mg
Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
|
Placebo-fingolimod 0.5
Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|---|
|
Core Study (24 Months)
Withdrawal by Subject
|
31
|
17
|
28
|
0
|
0
|
|
Core Study (24 Months)
Adverse Event
|
22
|
13
|
18
|
0
|
0
|
|
Core Study (24 Months)
Unsatisfactory therapeutic effect
|
13
|
6
|
25
|
0
|
0
|
|
Core Study (24 Months)
Abnormal laboratory value(s)
|
20
|
9
|
1
|
0
|
0
|
|
Core Study (24 Months)
Lost to Follow-up
|
3
|
5
|
7
|
0
|
0
|
|
Core Study (24 Months)
Protocol Violation
|
5
|
5
|
4
|
0
|
0
|
|
Core Study (24 Months)
Abnormal test procedure result(s)
|
2
|
1
|
1
|
0
|
0
|
|
Core Study (24 Months)
Death
|
1
|
0
|
2
|
0
|
0
|
|
Extension Study (Month 24 to 60)
Abnormal laboratory value(s)
|
10
|
5
|
0
|
8
|
3
|
|
Extension Study (Month 24 to 60)
Abnormal test procedure result(s)
|
3
|
1
|
0
|
1
|
3
|
|
Extension Study (Month 24 to 60)
Administrative problems
|
0
|
0
|
0
|
1
|
0
|
|
Extension Study (Month 24 to 60)
Adverse Event
|
6
|
9
|
0
|
6
|
10
|
|
Extension Study (Month 24 to 60)
Lost to Follow-up
|
2
|
0
|
0
|
1
|
1
|
|
Extension Study (Month 24 to 60)
Protocol Violation
|
1
|
1
|
0
|
0
|
0
|
|
Extension Study (Month 24 to 60)
Subject withdrew consent
|
19
|
23
|
0
|
15
|
9
|
|
Extension Study (Month 24 to 60)
Subject no longer requires study drug
|
0
|
1
|
0
|
0
|
0
|
|
Extension Study (Month 24 to 60)
Unsatisfactory therapeutic effect
|
3
|
1
|
0
|
1
|
3
|
Baseline Characteristics
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Fingolimod 1.25 mg
n=289 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=331 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod 1.25 mg
n=145 Participants
Patients randomized to placebo in the core study were re randomized to fingolimod 1.25 mg/day in this extension study.
|
Placebo-fingolimod 0.5 mg
n=155 Participants
Patients randomized to placebo in the core study were re randomized to fingolimod 0.5 mg/day in this extension study.
|
Total
n=920 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
37.2 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 8.60 • n=7 Participants
|
36.6 years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 8.26 • n=4 Participants
|
37.0 years
STANDARD_DEVIATION 8.73 • n=21 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
651 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
269 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Months 0 to end of study (maximum up to 60 months)Population: Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=429 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=425 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=418 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
|
0.164 Relapses per year
Interval 0.138 to 0.195
|
0.185 Relapses per year
Interval 0.158 to 0.217
|
0.357 Relapses per year
Interval 0.31 to 0.411
|
—
|
PRIMARY outcome
Timeframe: Core baseline to end of study (maximum up to 60 months)Population: Core Intent to treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=429 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=425 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=418 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
|
59.85 Percentage of patients
Interval 53.9 to 65.8
|
59.29 Percentage of patients
Interval 54.17 to 64.41
|
37.18 Percentage of patients
Interval 32.15 to 42.22
|
—
|
PRIMARY outcome
Timeframe: Months 0-24 (core study) and Months 24-48 (extension study)Population: Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=287 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=330 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=145 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
n=154 Participants
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 0-24
|
0.064 Relapses per year
Interval 0.043 to 0.094
|
0.111 Relapses per year
Interval 0.084 to 0.148
|
0.301 Relapses per year
Interval 0.23 to 0.393
|
0.292 Relapses per year
Interval 0.222 to 0.383
|
|
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 24-48
|
0.074 Relapses per year
Interval 0.051 to 0.108
|
0.095 Relapses per year
Interval 0.07 to 0.128
|
0.164 Relapses per year
Interval 0.117 to 0.231
|
0.130 Relapses per year
Interval 0.092 to 0.184
|
PRIMARY outcome
Timeframe: Months 0-24 (core study) and Months 24-48 (extension study)Population: Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=287 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=330 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=145 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
n=154 Participants
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
|
1.164 Ratio of relapses per year
Interval 0.83 to 1.633
|
0.850 Ratio of relapses per year
Interval 0.658 to 1.099
|
0.547 Ratio of relapses per year
Interval 0.39 to 0.767
|
0.446 Ratio of relapses per year
Interval 0.32 to 0.62
|
SECONDARY outcome
Timeframe: Months 0-24 (core study) and Months 24-48 (extension study)Population: Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=123 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=163 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=64 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
n=69 Participants
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 0-24
|
2.14 Lesions
Standard Deviation 5.234
|
2.66 Lesions
Standard Deviation 9.395
|
12.83 Lesions
Standard Deviation 17.573
|
8.12 Lesions
Standard Deviation 11.083
|
|
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 24-48
|
1.71 Lesions
Standard Deviation 4.902
|
2.58 Lesions
Standard Deviation 9.256
|
2.34 Lesions
Standard Deviation 4.745
|
1.43 Lesions
Standard Deviation 2.446
|
|
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Change from Months 0-24 to Months 24-48
|
-0.43 Lesions
Standard Deviation 4.393
|
-0.09 Lesions
Standard Deviation 7.423
|
-10.48 Lesions
Standard Deviation 15.980
|
-6.68 Lesions
Standard Deviation 9.876
|
SECONDARY outcome
Timeframe: Months 0-24 (core study) and Months 24-48 (extension study)Population: Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug. The analysis included number of patients with evaluable T2 MRI scans.
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=126 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=163 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=65 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
n=69 Participants
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 0-24
|
53.2 Percentage of patients
|
50.3 Percentage of patients
|
18.5 Percentage of patients
|
23.2 Percentage of patients
|
|
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Months 24-48
|
57.1 Percentage of patients
|
69.3 Percentage of patients
|
52.3 Percentage of patients
|
55.1 Percentage of patients
|
SECONDARY outcome
Timeframe: Months 0-24 (core study) and Months 24-48 (extension study)Population: Extension intent-to-treat (ITT) population: All extension randomized patients that received at least 1 dose of extension study drug.
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=287 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=330 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=145 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
n=154 Participants
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Month 0 to Month 24, n=75, 109, 41, 49
|
-1.011 Percent change
Standard Deviation 1.3477
|
-0.983 Percent change
Standard Deviation 1.6291
|
-1.511 Percent change
Standard Deviation 1.6401
|
-1.419 Percent change
Standard Deviation 1.3923
|
|
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Month 24 to Month 48, n=75, 109, 41, 49
|
-0.871 Percent change
Standard Deviation 1.4164
|
-0.780 Percent change
Standard Deviation 1.9266
|
-1.103 Percent change
Standard Deviation 1.4073
|
-0.903 Percent change
Standard Deviation 1.1406
|
SECONDARY outcome
Timeframe: Months 0 to end of study (maximum up to 60 months)Population: Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug. This analysis included only patients with value at both core baseline and end of study.
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=250 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=299 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=259 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
|
-1.639 Percent change
Standard Deviation 1.9265
|
-1.674 Percent change
Standard Deviation 2.1182
|
-2.241 Percent change
Standard Deviation 2.1873
|
—
|
SECONDARY outcome
Timeframe: Core baseline to end of study (maximum up to 60 months)Population: Core intent-to-treat (ITT) population: All patients who were randomized in the Core study and received at least 1 dose of Core study drug.
Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=429 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 1.25 mg/day, in this extension study.
|
Fingolimod 0.5 mg
n=425 Participants
Patients continued the same dose to which they had been randomized in the core study, fingolimod 0.5 mg/day, in this extension study.
|
Placebo-fingolimod
n=418 Participants
Patients randomized to placebo in the Core study who were subsequently re-randomized to FTY720 (either 1.25 or 0.5 mg/day) in the Extension study.
|
Placebo-fingolimod 0.5 mg
Patients randomized to placebo in the core study were re-randomized to fingolimod 0.5 mg/day in this extension study.
|
|---|---|---|---|---|
|
Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
|
74.15 Percentage of patients
Interval 69.54 to 78.75
|
73.90 Percentage of patients
Interval 69.44 to 78.37
|
66.28 Percentage of patients
Interval 61.28 to 71.28
|
—
|
Adverse Events
Fingolimod 1.25mg
Serious events: 31 serious events
Other events: 236 other events
Deaths: 0 deaths
Fingolimod 0.5mg
Serious events: 31 serious events
Other events: 273 other events
Deaths: 0 deaths
Placebo-Fingolimod 1.25mg
Serious events: 17 serious events
Other events: 107 other events
Deaths: 0 deaths
Placebo-Fingolimod 0.5mg
Serious events: 11 serious events
Other events: 130 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fingolimod 1.25mg
n=289 participants at risk
Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
|
Fingolimod 0.5mg
n=331 participants at risk
Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
|
Placebo-Fingolimod 1.25mg
n=145 participants at risk
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
|
Placebo-Fingolimod 0.5mg
n=155 participants at risk
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Angina pectoris
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Atrioventricular extrasystoles
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Palpitations
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Sinus bradycardia
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
General disorders
Fatigue
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.69%
2/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Appendicitis
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.60%
2/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Cellulitis
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Gastroenteritis viral
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Genital infection
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Herpes zoster
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Herpes zoster oticus
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Influenza
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Lobar pneumonia
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Tracheitis
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.69%
2/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.91%
3/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
1.4%
2/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Borderline ovarian tumour
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eyelid
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.60%
2/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.60%
2/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Migraine
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.0%
3/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Neuralgia
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Syncope
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Depression
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
1.4%
2/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Personality disorder
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Reproductive system and breast disorders
Breast mass
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.65%
1/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Skin and subcutaneous tissue disorders
Lymphomatoid papulosis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Surgical and medical procedures
Selective abortion
|
0.35%
1/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Vascular disorders
Hypertension
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.30%
1/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.69%
1/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
0.00%
0/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
Other adverse events
| Measure |
Fingolimod 1.25mg
n=289 participants at risk
Patients randomized to fingolimod 1.25 mg/day in the Core study. These patients continued the same dose in the Extension study.
|
Fingolimod 0.5mg
n=331 participants at risk
Patients randomized to fingolimod 0.5 mg/day in the Core study. These patients continued the same dose in the Extension study.
|
Placebo-Fingolimod 1.25mg
n=145 participants at risk
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 1.25 mg/day in the Extension study.
|
Placebo-Fingolimod 0.5mg
n=155 participants at risk
Patients randomized to placebo in the Core study who were subsequently re-randomized to fingolimod 0.5 mg/day in the Extension study.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.0%
52/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
15.7%
52/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
12.4%
18/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
11.0%
17/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
14/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.8%
29/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.9%
10/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.5%
10/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
General disorders
Fatigue
|
4.2%
12/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.9%
23/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
7/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.2%
8/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Bronchitis
|
6.6%
19/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.0%
20/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.9%
10/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.1%
11/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Cystitis
|
2.4%
7/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.6%
12/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.5%
8/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
1.9%
3/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Gastroenteritis
|
5.2%
15/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.3%
11/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.1%
3/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.2%
5/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Influenza
|
10.4%
30/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
10.0%
33/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.2%
9/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.7%
12/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Nasopharyngitis
|
28.4%
82/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
25.4%
84/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
26.9%
39/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
28.4%
44/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Oral herpes
|
6.6%
19/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.3%
24/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.9%
10/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.1%
11/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Pharyngitis
|
4.8%
14/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.1%
17/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.5%
8/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.2%
5/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Sinusitis
|
2.8%
8/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.5%
15/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
7/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.5%
10/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.5%
39/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
17.5%
58/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
15.9%
23/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
15.5%
24/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Infections and infestations
Urinary tract infection
|
6.9%
20/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.2%
27/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.3%
12/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.2%
8/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
10/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.3%
11/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
11.0%
16/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.8%
9/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
7.3%
21/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
16/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.9%
10/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.8%
9/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.4%
7/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.4%
8/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.3%
12/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.2%
8/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
29/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
16/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.3%
12/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
9.0%
14/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Investigations
Weight decreased
|
1.0%
3/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
1.8%
6/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.8%
4/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.7%
12/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
6.2%
18/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.3%
24/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
7/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.4%
13/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
20/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.3%
21/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.1%
6/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.2%
8/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
20/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.3%
21/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.3%
12/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
9.0%
14/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
15/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.4%
18/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.2%
9/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.2%
8/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
7.6%
22/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.8%
16/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.8%
4/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.6%
4/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
5.2%
15/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.0%
10/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
3.4%
5/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
1.9%
3/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Dizziness
|
2.4%
7/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
2.1%
7/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
4.1%
6/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
6.5%
10/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Nervous system disorders
Headache
|
9.3%
27/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
12.4%
41/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
12.4%
18/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
16.8%
26/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
19/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
8.2%
27/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
9.0%
13/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
7.1%
11/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
|
Vascular disorders
Hypertension
|
8.3%
24/289
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
5.4%
18/331
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
9.0%
13/145
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
9.7%
15/155
Safety reported on extension safety population which includes all patients who received at least 1 dose of Extension study drug. Patients were analyzed according to the actual treatment received during extension.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER