Trial Outcomes & Findings for Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase (NCT NCT00340834)
NCT ID: NCT00340834
Last Updated: 2017-09-21
Results Overview
The 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1292 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2017-09-21
Participant Flow
Patients randomized in the Core Phase (CP) to receive 0.5 mg or 1.25 mg fingolimod received the same dose in the Extension Phase (EP). Patients randomized to receive interferon-β-1a in the CP were re-randomized to receive either 0.5 mg or 1.25 mg fingolimod in a 1:1 ratio in the EP. Upon protocol amendment, all patients received 0.5 mg fingolimod.
Participant milestones
| Measure |
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a 30 µg
Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
|
Interferon β-1a/Fingolimod 1.25 mg
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
|
Interferon β-1a/Fingolimod 0.5 mg
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
|
|---|---|---|---|---|---|
|
Core Phase of Study
STARTED
|
426
|
431
|
435
|
0
|
0
|
|
Core Phase of Study
COMPLETED
|
369
|
398
|
386
|
0
|
0
|
|
Core Phase of Study
NOT COMPLETED
|
57
|
33
|
49
|
0
|
0
|
|
Extension Phase of Study
STARTED
|
330
|
357
|
0
|
176
|
167
|
|
Extension Phase of Study
Received Study Drug
|
330
|
356
|
0
|
174
|
167
|
|
Extension Phase of Study
COMPLETED
|
245
|
281
|
0
|
123
|
123
|
|
Extension Phase of Study
NOT COMPLETED
|
85
|
76
|
0
|
53
|
44
|
Reasons for withdrawal
| Measure |
Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a 30 µg
Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
|
Interferon β-1a/Fingolimod 1.25 mg
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
|
Interferon β-1a/Fingolimod 0.5 mg
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
|
|---|---|---|---|---|---|
|
Core Phase of Study
Adverse Event
|
26
|
9
|
9
|
0
|
0
|
|
Core Phase of Study
Withdrawal by Subject
|
11
|
9
|
16
|
0
|
0
|
|
Core Phase of Study
Administrative Problems
|
6
|
2
|
7
|
0
|
0
|
|
Core Phase of Study
Lack of Efficacy
|
3
|
3
|
7
|
0
|
0
|
|
Core Phase of Study
Abnormal laboratory value(s)
|
4
|
6
|
1
|
0
|
0
|
|
Core Phase of Study
Abnormal test procedure result(s)
|
4
|
3
|
3
|
0
|
0
|
|
Core Phase of Study
Lost to Follow-up
|
1
|
1
|
4
|
0
|
0
|
|
Core Phase of Study
Death
|
2
|
0
|
0
|
0
|
0
|
|
Core Phase of Study
Protocol Violation
|
0
|
0
|
2
|
0
|
0
|
|
Extension Phase of Study
Subject did not receive study drug
|
0
|
1
|
0
|
2
|
0
|
|
Extension Phase of Study
Subject withdrew consent
|
26
|
31
|
0
|
12
|
15
|
|
Extension Phase of Study
Adverse Event
|
21
|
22
|
0
|
19
|
7
|
|
Extension Phase of Study
Abnormal laboratory value(s)
|
14
|
13
|
0
|
13
|
4
|
|
Extension Phase of Study
Unsatisfactory therapeutic effect
|
13
|
7
|
0
|
4
|
9
|
|
Extension Phase of Study
Lost to Follow-up
|
1
|
1
|
0
|
2
|
3
|
|
Extension Phase of Study
Subject no longer requires study drug
|
4
|
0
|
0
|
0
|
2
|
|
Extension Phase of Study
Administrative problems
|
3
|
0
|
0
|
1
|
1
|
|
Extension Phase of Study
Abnormal test procedure result(s)
|
0
|
1
|
0
|
0
|
2
|
|
Extension Phase of Study
Protocol Violation
|
3
|
0
|
0
|
0
|
0
|
|
Extension Phase of Study
Death
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Baseline characteristics by cohort
| Measure |
Fingolimod 1.25 mg
n=426 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=431 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a 30 µg
n=435 Participants
Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
|
Interferon β-1a/Fingolimod 1.25 mg
n=174 Participants
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
|
Interferon β-1a/Fingolimod 0.5 mg
n=167 Participants
Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
|
Total
n=1633 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.5 Years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
36.5 Years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
NA Years
STANDARD_DEVIATION NA • n=5 Participants
|
36.1 Years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
36.1 Years
STANDARD_DEVIATION 8.59 • n=21 Participants
|
36.0 Years
STANDARD_DEVIATION 8.48 • n=10 Participants
|
|
Age, Customized
< 18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
18-30
|
100 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
285 Participants
n=10 Participants
|
|
Age, Customized
31-40
|
122 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
394 Participants
n=10 Participants
|
|
Age, Customized
41-55
|
108 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
348 Participants
n=10 Participants
|
|
Age, Customized
> 55
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Customized
>55
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Female
|
293 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
227 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
685 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
103 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
342 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.
The 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=420 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=429 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=431 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study
|
0.203 Estimate relapses per year
Interval 0.157 to 0.264
|
0.161 Estimate relapses per year
Interval 0.122 to 0.212
|
0.331 Estimate relapses per year
Interval 0.262 to 0.417
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (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=420 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=429 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=431 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study
|
1.6 T2 lesions
Standard Deviation 3.23
|
1.6 T2 lesions
Standard Deviation 3.16
|
2.6 T2 lesions
Standard Deviation 5.50
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=420 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=429 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=431 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study
|
93.3 Percentage of participants
Interval 90.92 to 95.77
|
94.1 Percentage of participants
Interval 91.82 to 96.33
|
92.1 Percentage of participants
Interval 89.45 to 94.66
|
SECONDARY outcome
Timeframe: Month 0 to end of study (up to approximately 4.5 years)Population: Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.
The 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 calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=420 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=429 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=431 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Month 12 to Month 24, n=330, 356, 341
|
0.156 Estimated relapses per year
Interval 0.114 to 0.214
|
0.182 Estimated relapses per year
Interval 0.138 to 0.242
|
0.266 Estimated relapses per year
Interval 0.207 to 0.341
|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Month 24 to Month 36, n=287, 321, 293
|
0.116 Estimated relapses per year
Interval 0.079 to 0.169
|
0.110 Estimated relapses per year
Interval 0.076 to 0.16
|
0.121 Estimated relapses per year
Interval 0.084 to 0.176
|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Month 36 to Month 48, n=267, 303, 271
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Month 48 to end of study, n=36, 38, 29
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
NA Estimated relapses per year
Not estimable due to sparse data.
|
|
Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study
Month 0 to end of study, n=420, 429, 431
|
0.192 Estimated relapses per year
Interval 0.16 to 0.229
|
0.166 Estimated relapses per year
Interval 0.139 to 0.199
|
0.271 Estimated relapses per year
Interval 0.23 to 0.318
|
SECONDARY outcome
Timeframe: Month 12 to end of study (up to approximately 3.5 years)Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (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=279 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=317 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=288 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Month 12 to Month 24
|
1.08 T2 lesions
Standard Deviation 2.644
|
0.87 T2 lesions
Standard Deviation 1.624
|
0.97 T2 lesions
Standard Deviation 1.923
|
|
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Month 24 to Month 36, n=255, 289, 258
|
1.40 T2 lesions
Standard Deviation 3.418
|
1.04 T2 lesions
Standard Deviation 4.408
|
0.72 T2 lesions
Standard Deviation 1.733
|
|
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Month 36 to Month 48, n=36, 34, 35
|
0.97 T2 lesions
Standard Deviation 1.682
|
0.59 T2 lesions
Standard Deviation 1.438
|
0.49 T2 lesions
Standard Deviation 1.483
|
|
Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study
Last MRI scan to end of study, n=275, 309, 290
|
1.75 T2 lesions
Standard Deviation 7.248
|
0.86 T2 lesions
Standard Deviation 2.674
|
1.03 T2 lesions
Standard Deviation 4.350
|
SECONDARY outcome
Timeframe: Baseline to end of study (up to approximately 4.5 years)Population: Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.
The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.
Outcome measures
| Measure |
Fingolimod 1.25 mg
n=420 Participants
Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Fingolimod 0.5 mg
n=429 Participants
Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
|
Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg
n=431 Participants
Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
|
|---|---|---|---|
|
Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study
Free of 3-month progression
|
67.01 Percentage of participants
Interval 57.26 to 95.77
|
71.28 Percentage of participants
Interval 63.69 to 78.87
|
73.40 Percentage of participants
Interval 68.56 to 78.23
|
|
Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study
Free of 6-month progression
|
79.54 Percentage of participants
Interval 75.07 to 84.0
|
79.76 Percentage of participants
Interval 75.53 to 83.98
|
81.61 Percentage of participants
Interval 77.39 to 85.83
|
Adverse Events
COR FTY720 1.25 mg
Serious events: 45 serious events
Other events: 310 other events
Deaths: 0 deaths
COR FTY720 0.5 mg
Serious events: 30 serious events
Other events: 302 other events
Deaths: 0 deaths
COR Interferon Beta-1a
Serious events: 25 serious events
Other events: 359 other events
Deaths: 0 deaths
EXT FTY720 1.25 mg
Serious events: 77 serious events
Other events: 446 other events
Deaths: 0 deaths
EXT FTY720 0.5 mg
Serious events: 76 serious events
Other events: 439 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COR FTY720 1.25 mg
n=420 participants at risk
COR FTY720 1.25 mg
|
COR FTY720 0.5 mg
n=429 participants at risk
COR FTY720 0.5 mg
|
COR Interferon Beta-1a
n=431 participants at risk
COR Interferon beta-1a
|
EXT FTY720 1.25 mg
n=504 participants at risk
EXT FTY720 1.25 mg
|
EXT FTY720 0.5 mg
n=523 participants at risk
EXT FTY720 0.5 mg
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Psychiatric disorders
Suicide attempt
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Reproductive system and breast disorders
Infertility
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.48%
2/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Vascular disorders
Arterial occlusive disease
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Vascular disorders
Hypertensive crisis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.60%
3/504
|
0.19%
1/523
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Arrhythmia
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.38%
2/523
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.48%
2/420
|
0.23%
1/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.71%
3/420
|
0.23%
1/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Cardiac disorders
Bradycardia
|
1.9%
8/420
|
0.23%
1/429
|
0.00%
0/431
|
0.60%
3/504
|
0.19%
1/523
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Palpitations
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Cardiac disorders
Sinus bradycardia
|
0.48%
2/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Cardiac disorders
Sinus tachycardia
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Congenital, familial and genetic disorders
Congenital absence of cranial vault
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Congenital, familial and genetic disorders
Congenital anomaly in offspring
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.79%
4/504
|
0.00%
0/523
|
|
Endocrine disorders
Goitre
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Eye disorders
Diplopia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Eye disorders
Macular oedema
|
0.24%
1/420
|
0.23%
1/429
|
0.00%
0/431
|
0.40%
2/504
|
0.19%
1/523
|
|
Eye disorders
Tolosa-Hunt syndrome
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Gastrointestinal disorders
Anal skin tags
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Constipation
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
General disorders
Abasia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
General disorders
Chest discomfort
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
General disorders
Complication of device insertion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
General disorders
Influenza like illness
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
General disorders
Multi-organ failure
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
General disorders
Pyrexia
|
0.24%
1/420
|
0.00%
0/429
|
0.23%
1/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.00%
0/504
|
0.76%
4/523
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Abscess sweat gland
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Administration site infection
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Anal abscess
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Appendicitis
|
0.48%
2/420
|
0.00%
0/429
|
0.46%
2/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Cystitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.38%
2/523
|
|
Infections and infestations
Encephalitis herpes
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Encephalitis viral
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Gastrointestinal candidiasis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Helicobacter gastritis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Herpes ophthalmic
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Herpes zoster
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.79%
4/504
|
0.19%
1/523
|
|
Infections and infestations
Herpes zoster disseminated
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Influenza
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Laryngitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Lower respiratory tract infection
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Pneumonia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.60%
3/504
|
0.19%
1/523
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Infections and infestations
Salpingitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Infections and infestations
Urosepsis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Varicella
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Infections and infestations
Viral infection
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Injury, poisoning and procedural complications
Complicated fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.38%
2/523
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.00%
0/504
|
0.38%
2/523
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Investigations
Hepatic enzyme increased
|
0.24%
1/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Investigations
Human papilloma virus test positive
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Investigations
Weight decreased
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.48%
2/420
|
0.47%
2/429
|
0.00%
0/431
|
0.79%
4/504
|
1.3%
7/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mediastinal neoplasm
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.48%
2/420
|
0.23%
1/429
|
0.00%
0/431
|
0.20%
1/504
|
0.38%
2/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/420
|
0.47%
2/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.19%
1/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.20%
1/504
|
0.38%
2/523
|
|
Nervous system disorders
Ataxia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.40%
2/504
|
0.00%
0/523
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Coma
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Demyelination
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Dural fistula
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Grand mal convulsion
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Headache
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Migraine
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/420
|
0.23%
1/429
|
0.23%
1/431
|
0.79%
4/504
|
1.1%
6/523
|
|
Nervous system disorders
Nerve root lesion
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Neuropathy peripheral
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/420
|
0.23%
1/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Paraparesis
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Presyncope
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Progressive relapsing multiple sclerosis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Radicular syndrome
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Sciatica
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Sensorimotor disorder
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Spinal cord ischaemia
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Nervous system disorders
Status epilepticus
|
0.24%
1/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Nervous system disorders
Tension headache
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.00%
0/420
|
0.00%
0/429
|
0.23%
1/431
|
0.00%
0/504
|
0.00%
0/523
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.38%
2/523
|
|
Pregnancy, puerperium and perinatal conditions
Complication of pregnancy
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.20%
1/504
|
0.00%
0/523
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/420
|
0.00%
0/429
|
0.00%
0/431
|
0.00%
0/504
|
0.19%
1/523
|
Other adverse events
| Measure |
COR FTY720 1.25 mg
n=420 participants at risk
COR FTY720 1.25 mg
|
COR FTY720 0.5 mg
n=429 participants at risk
COR FTY720 0.5 mg
|
COR Interferon Beta-1a
n=431 participants at risk
COR Interferon beta-1a
|
EXT FTY720 1.25 mg
n=504 participants at risk
EXT FTY720 1.25 mg
|
EXT FTY720 0.5 mg
n=523 participants at risk
EXT FTY720 0.5 mg
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.71%
3/420
|
0.23%
1/429
|
0.00%
0/431
|
21.4%
108/504
|
14.7%
77/523
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
35/420
|
7.5%
32/429
|
4.9%
21/431
|
9.5%
48/504
|
9.6%
50/523
|
|
Gastrointestinal disorders
Nausea
|
6.9%
29/420
|
9.3%
40/429
|
6.7%
29/431
|
7.3%
37/504
|
6.9%
36/523
|
|
Gastrointestinal disorders
Toothache
|
4.3%
18/420
|
2.8%
12/429
|
2.1%
9/431
|
2.6%
13/504
|
6.3%
33/523
|
|
General disorders
Fatigue
|
14.3%
60/420
|
10.3%
44/429
|
10.4%
45/431
|
7.7%
39/504
|
7.6%
40/523
|
|
General disorders
Influenza like illness
|
3.6%
15/420
|
3.5%
15/429
|
36.7%
158/431
|
4.8%
24/504
|
3.4%
18/523
|
|
General disorders
Pyrexia
|
3.3%
14/420
|
4.2%
18/429
|
17.6%
76/431
|
6.5%
33/504
|
5.7%
30/523
|
|
Infections and infestations
Bronchitis
|
4.5%
19/420
|
4.7%
20/429
|
2.6%
11/431
|
7.7%
39/504
|
9.4%
49/523
|
|
Infections and infestations
Gastroenteritis
|
2.9%
12/420
|
2.3%
10/429
|
2.6%
11/431
|
6.2%
31/504
|
6.9%
36/523
|
|
Infections and infestations
Influenza
|
6.7%
28/420
|
6.8%
29/429
|
7.4%
32/431
|
8.7%
44/504
|
9.9%
52/523
|
|
Infections and infestations
Nasopharyngitis
|
22.1%
93/420
|
20.5%
88/429
|
20.4%
88/431
|
31.3%
158/504
|
31.0%
162/523
|
|
Infections and infestations
Oral herpes
|
2.1%
9/420
|
0.70%
3/429
|
1.6%
7/431
|
7.1%
36/504
|
6.5%
34/523
|
|
Infections and infestations
Pharyngitis
|
4.5%
19/420
|
3.0%
13/429
|
3.0%
13/431
|
4.0%
20/504
|
5.9%
31/523
|
|
Infections and infestations
Sinusitis
|
4.3%
18/420
|
2.3%
10/429
|
2.6%
11/431
|
6.7%
34/504
|
6.9%
36/523
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
36/420
|
7.2%
31/429
|
6.3%
27/431
|
14.9%
75/504
|
11.3%
59/523
|
|
Infections and infestations
Urinary tract infection
|
5.7%
24/420
|
6.1%
26/429
|
4.9%
21/431
|
9.7%
49/504
|
11.1%
58/523
|
|
Investigations
Alanine aminotransferase increased
|
5.7%
24/420
|
6.5%
28/429
|
1.9%
8/431
|
8.7%
44/504
|
6.5%
34/523
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
19/420
|
3.3%
14/429
|
0.23%
1/431
|
6.3%
32/504
|
4.8%
25/523
|
|
Investigations
Lymphocyte count decreased
|
0.24%
1/420
|
0.47%
2/429
|
0.00%
0/431
|
14.3%
72/504
|
8.0%
42/523
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.1%
9/420
|
2.3%
10/429
|
0.70%
3/431
|
3.8%
19/504
|
6.1%
32/523
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
17/420
|
2.8%
12/429
|
5.6%
24/431
|
7.5%
38/504
|
7.5%
39/523
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
27/420
|
6.1%
26/429
|
5.3%
23/431
|
11.9%
60/504
|
10.1%
53/523
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
14/420
|
3.3%
14/429
|
10.2%
44/431
|
3.0%
15/504
|
3.1%
16/523
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
20/420
|
4.9%
21/429
|
6.5%
28/431
|
7.7%
39/504
|
5.2%
27/523
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
10.0%
42/420
|
6.5%
28/429
|
5.6%
24/431
|
10.5%
53/504
|
9.8%
51/523
|
|
Nervous system disorders
Dizziness
|
5.5%
23/420
|
6.1%
26/429
|
4.9%
21/431
|
5.0%
25/504
|
4.4%
23/523
|
|
Nervous system disorders
Headache
|
22.9%
96/420
|
23.1%
99/429
|
20.4%
88/431
|
17.1%
86/504
|
20.5%
107/523
|
|
Psychiatric disorders
Depression
|
4.3%
18/420
|
4.9%
21/429
|
7.4%
32/431
|
7.9%
40/504
|
8.4%
44/523
|
|
Psychiatric disorders
Insomnia
|
4.5%
19/420
|
4.0%
17/429
|
3.0%
13/431
|
6.3%
32/504
|
5.7%
30/523
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
30/420
|
4.7%
20/429
|
3.7%
16/431
|
10.7%
54/504
|
10.1%
53/523
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
21/420
|
1.9%
8/429
|
1.6%
7/431
|
3.4%
17/504
|
2.7%
14/523
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
20/420
|
4.0%
17/429
|
3.5%
15/431
|
6.2%
31/504
|
7.3%
38/523
|
|
Vascular disorders
Hypertension
|
5.0%
21/420
|
3.7%
16/429
|
1.9%
8/431
|
7.3%
37/504
|
5.5%
29/523
|
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