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Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS)

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ClinicalTrials.gov Identifier: NCT00289978
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 16, 2011
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Relapsing-remitting Multiple Sclerosis
Interventions Drug: Fingolimod 1.25 mg
Drug: Fingolimod 0.5 mg
Drug: Placebo
Enrollment 1272

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Hide Arm/Group Description Patients self-administered fingolimod 1.25 mg capsules orally once daily. Patients self-administered fingolimod 0.5 mg capsules orally once daily. Patients self-administered a fingolimod placebo capsule orally once daily.
Period Title: Overall Study
Started 429 425 418
Completed 332 [1] 369 [2] 332 [3]
Not Completed 97 56 86
Reason Not Completed
Withdrawal by Subject             31             17             28
Adverse Event             22             13             18
Lack of Efficacy             13             6             25
Abnormal laboratory value(s)             20             9             1
Lost to Follow-up             3             5             7
Protocol Violation             5             5             4
Abnormal test procedure result(s)             2             1             1
Death             1             0             2
[1]
296 completed on study drug, 35 completed off study drug.
[2]
345 completed on study drug, 24 completed off study drug.
[3]
303 completed on study drug, 29 completed off study drug.
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo Total
Hide Arm/Group Description Patients self-administered fingolimod 1.25 mg capsules orally once daily. Patients self-administered fingolimod 0.5 mg capsules orally once daily. Patients self-administered a fingolimod placebo capsule orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 429 425 418 1272
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
37.4  (8.91) 36.6  (8.77) 37.2  (8.60) 37.1  (8.76)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
<18 years 1 0 0 1
18 -30 107 120 97 324
31-40 147 162 165 474
41-55 174 143 156 473
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
Female
295
  68.8%
296
  69.6%
298
  71.3%
889
  69.9%
Male
134
  31.2%
129
  30.4%
120
  28.7%
383
  30.1%
Duration of multiple sclerosis since first symptoms  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
8.4  (6.86) 8.0  (6.60) 8.1  (6.35) 8.2  (6.60)
Number of relapses in last 2 years  
Mean (Standard Deviation)
Unit of measure:  Relapses
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
1.5  (0.81) 1.5  (0.76) 1.4  (0.73) 1.5  (0.77)
Expanded Disability Status Scale (EDSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 429 participants 425 participants 418 participants 1272 participants
2.41  (1.36) 2.30  (1.29) 2.49  (1.29) 2.40  (1.32)
[1]
Measure Description: The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). Based on scores in these 8 functional systems, an overall score ranging from 0 (normal) to 10 (death due to MS) is assigned. Patients with EDSS scores of 0.0 to 4.5 are fully ambulatory; patients with EDSS scores of 5.0 to 9.5 have impaired ambulation. EDSS was assessed by an evaluating physician at each site.
1.Primary Outcome
Title Estimated Annualized Aggregate Relapse Rate (ARR)
Hide Description 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 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.
Time Frame Baseline to end of study (Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis was conducted using the Intent-to-treat (ITT) population which includes all patients who were randomized and received at least one dose of study drug.
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Hide Arm/Group Description:
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Patients self-administered a fingolimod placebo capsule orally once daily.
Overall Number of Participants Analyzed 429 425 418
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Relapses per year
0.16
(0.13 to 0.19)
0.18
(0.15 to 0.22)
0.40
(0.34 to 0.47)
2.Secondary Outcome
Title Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)
Hide Description EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: 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. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.
Time Frame Baseline to end of study (Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Hide Arm/Group Description:
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Patients self-administered a fingolimod placebo capsule orally once daily.
Overall Number of Participants Analyzed 429 425 418
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
83.4
(79.7 to 87.1)
82.3
(78.6 to 86.1)
75.9
(71.7 to 80.2)
3.Secondary Outcome
Title Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline
Hide Description The number of new or newly enlarged T2 lesions at Month 24 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.
Time Frame Baseline to end of study (Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): All patients who were randomized and received at least one dose of study medication.
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Hide Arm/Group Description:
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Patients self-administered a fingolimod placebo capsule orally once daily.
Overall Number of Participants Analyzed 429 425 418
Overall Number of Units Analyzed
Type of Units Analyzed: Patients with non-missing values
337 370 339
Mean (Standard Deviation)
Unit of Measure: T2 lesions
2.5  (5.52) 2.5  (7.19) 9.8  (13.17)
Time Frame 24 Months
Adverse Event Reporting Description Adverse events are reported based on the safety population. The safety population consists of all patients who received at least 1 dose of study drug.
 
Arm/Group Title Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Hide Arm/Group Description Patients self-administered fingolimod 1.25 mg capsules orally once daily. Patients self-administered fingolimod 0.5 mg capsules orally once daily. Patients self-administered a fingolimod placebo capsule orally once daily.
All-Cause Mortality
Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/429 (11.89%)   43/425 (10.12%)   56/418 (13.40%) 
Blood and lymphatic system disorders       
Leukopenia  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Lymphopenia  1  2/429 (0.47%)  0/425 (0.00%)  0/418 (0.00%) 
Thrombocytopenia  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Cardiac disorders       
Angina pectoris  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Atrioventricular block first degree  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Atrioventricular block second degree  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Bradycardia  1  3/429 (0.70%)  4/425 (0.94%)  1/418 (0.24%) 
Left ventricular dysfunction  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Myocardial infarction  1  0/429 (0.00%)  0/425 (0.00%)  2/418 (0.48%) 
Palpitations  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Pericarditis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Supraventricular extrasystoles  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Tachycardia paroxysmal  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Ventricular tachycardia  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Eye disorders       
Eye pain  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Iridocyclitis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Keratitis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Macular oedema  1  3/429 (0.70%)  0/425 (0.00%)  0/418 (0.00%) 
Papilloedema  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Photopsia  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Retinal detachment  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Retinal disorder  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Retinitis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  0/429 (0.00%)  1/425 (0.24%)  1/418 (0.24%) 
Abdominal pain upper  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Constipation  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Diarrhoea  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Dyspepsia  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Gastritis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Haemorrhoids  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Ileus paralytic  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Inguinal hernia  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Oesophagitis  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Pancreatitis chronic  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Vomiting  1  0/429 (0.00%)  1/425 (0.24%)  1/418 (0.24%) 
General disorders       
Chest pain  1  0/429 (0.00%)  2/425 (0.47%)  0/418 (0.00%) 
Fatigue  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Haemorrhagic cyst  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Inflammation  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Non-cardiac chest pain  1  0/429 (0.00%)  2/425 (0.47%)  2/418 (0.48%) 
Hepatobiliary disorders       
Biliary colic  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Cholelithiasis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Cytolytic hepatitis  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Hepatic steatosis  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Hepatomegaly  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Infections and infestations       
Abscess  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Abscess jaw  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Acute sinusitis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Anal abscess  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Appendicitis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Clostridial infection  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Cystitis  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Dermo-hypodermitis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Gastroenteritis  1  0/429 (0.00%)  1/425 (0.24%)  1/418 (0.24%) 
Genital herpes  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Herpes virus infection  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Mastoiditis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Otitis media acute  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Peritoneal abscess  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Peritonsillitis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Pharyngitis  1  0/429 (0.00%)  1/425 (0.24%)  1/418 (0.24%) 
Pharyngotonsillitis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Pneumonia  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Pyelonephritis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Pyelonephritis acute  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Pyelonephritis chronic  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Respiratory tract infection  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Sinusitis  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Streptococcal abscess  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Tonsillitis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Tooth abscess  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Upper respiratory tract infection  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Urinary tract infection  1  0/429 (0.00%)  2/425 (0.47%)  0/418 (0.00%) 
Urosepsis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Injury, poisoning and procedural complications       
Burns second degree  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Fractured coccyx  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Head injury  1  0/429 (0.00%)  1/425 (0.24%)  1/418 (0.24%) 
Ligament rupture  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Lower limb fracture  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Overdose  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Road traffic accident  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Splenic injury  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Splenic rupture  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Subdural haematoma  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Investigations       
Alanine aminotransferase increased  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Aspartate aminotransferase increased  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Electrocardiogram PR prolongation  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Electrocardiogram change  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Gamma-glutamyltransferase increased  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Hepatic enzyme increased  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Liver function test abnormal  1  2/429 (0.47%)  0/425 (0.00%)  1/418 (0.24%) 
Precancerous cells present  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Red blood cell sedimentation rate increased  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Arthritis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Back pain  1  0/429 (0.00%)  2/425 (0.47%)  1/418 (0.24%) 
Bursitis  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Intervertebral disc protrusion  1  0/429 (0.00%)  0/425 (0.00%)  2/418 (0.48%) 
Myalgia  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Pain in extremity  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/429 (0.23%)  4/425 (0.94%)  2/418 (0.48%) 
Benign ovarian tumour  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Bowen's disease  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Brain neoplasm benign  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Breast cancer  1  1/429 (0.23%)  0/425 (0.00%)  3/418 (0.72%) 
Cervix carcinoma stage 0  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Endometrial cancer  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Malignant melanoma  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Ovarian adenoma  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Prostate cancer  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Uterine leiomyoma  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Nervous system disorders       
Amnesia  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Central nervous system lesion  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Cerebrovascular accident  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Epilepsy  1  2/429 (0.47%)  0/425 (0.00%)  0/418 (0.00%) 
Grand mal convulsion  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Headache  1  2/429 (0.47%)  0/425 (0.00%)  0/418 (0.00%) 
Ischaemic stroke  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Migraine with aura  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Monoplegia  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Multiple sclerosis  1  0/429 (0.00%)  2/425 (0.47%)  0/418 (0.00%) 
Multiple sclerosis relapse  1  3/429 (0.70%)  2/425 (0.47%)  1/418 (0.24%) 
Partial seizures with secondary generalisation  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Presyncope  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Sciatica  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Somnolence  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Syncope  1  1/429 (0.23%)  1/425 (0.24%)  1/418 (0.24%) 
Pregnancy, puerperium and perinatal conditions       
Abortion  1  0/429 (0.00%)  0/425 (0.00%)  3/418 (0.72%) 
Abortion spontaneous  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Psychiatric disorders       
Acute psychosis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Anxiety  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Depression  1  2/429 (0.47%)  0/425 (0.00%)  1/418 (0.24%) 
Homicidal ideation  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Renal and urinary disorders       
Nephrolithiasis  1  1/429 (0.23%)  1/425 (0.24%)  0/418 (0.00%) 
Renal colic  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Renal cyst  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Reproductive system and breast disorders       
Cervical dysplasia  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Endometriosis  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Metrorrhagia  1  1/429 (0.23%)  0/425 (0.00%)  1/418 (0.24%) 
Ovarian cyst  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Ovarian disorder  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Chronic obstructive pulmonary disease  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Dyspnoea exertional  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Pleurisy  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Pneumonia aspiration  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Productive cough  1  1/429 (0.23%)  0/425 (0.00%)  0/418 (0.00%) 
Pulmonary embolism  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Pulmonary oedema  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash macular  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Urticaria  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Vascular disorders       
Circulatory collapse  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Hypertension  1  0/429 (0.00%)  0/425 (0.00%)  1/418 (0.24%) 
Varicose vein  1  0/429 (0.00%)  1/425 (0.24%)  0/418 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fingolimod 1.25 mg Fingolimod 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   346/429 (80.65%)   355/425 (83.53%)   323/418 (77.27%) 
Ear and labyrinth disorders       
Vertigo  1  18/429 (4.20%)  18/425 (4.24%)  21/418 (5.02%) 
Gastrointestinal disorders       
Diarrhoea  1  40/429 (9.32%)  50/425 (11.76%)  30/418 (7.18%) 
Nausea  1  38/429 (8.86%)  38/425 (8.94%)  36/418 (8.61%) 
General disorders       
Fatigue  1  46/429 (10.72%)  48/425 (11.29%)  45/418 (10.77%) 
Infections and infestations       
Bronchitis  1  39/429 (9.09%)  34/425 (8.00%)  15/418 (3.59%) 
Influenza  1  40/429 (9.32%)  55/425 (12.94%)  41/418 (9.81%) 
Nasopharyngitis  1  112/429 (26.11%)  115/425 (27.06%)  115/418 (27.51%) 
Pharyngitis  1  25/429 (5.83%)  26/425 (6.12%)  23/418 (5.50%) 
Rhinitis  1  18/429 (4.20%)  25/425 (5.88%)  25/418 (5.98%) 
Sinusitis  1  27/429 (6.29%)  27/425 (6.35%)  19/418 (4.55%) 
Upper respiratory tract infection  1  62/429 (14.45%)  73/425 (17.18%)  72/418 (17.22%) 
Urinary tract infection  1  21/429 (4.90%)  34/425 (8.00%)  47/418 (11.24%) 
Investigations       
Alanine aminotransferase increased  1  49/429 (11.42%)  42/425 (9.88%)  16/418 (3.83%) 
Gamma-glutamyltransferase increased  1  31/429 (7.23%)  22/425 (5.18%)  4/418 (0.96%) 
Weight increased  1  14/429 (3.26%)  14/425 (3.29%)  22/418 (5.26%) 
Metabolism and nutrition disorders       
Hypercholesterolaemia  1  26/429 (6.06%)  24/425 (5.65%)  26/418 (6.22%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  26/429 (6.06%)  30/425 (7.06%)  33/418 (7.89%) 
Back pain  1  45/429 (10.49%)  49/425 (11.53%)  28/418 (6.70%) 
Pain in extremity  1  24/429 (5.59%)  28/425 (6.59%)  27/418 (6.46%) 
Nervous system disorders       
Dizziness  1  31/429 (7.23%)  31/425 (7.29%)  23/418 (5.50%) 
Headache  1  113/429 (26.34%)  107/425 (25.18%)  96/418 (22.97%) 
Paraesthesia  1  17/429 (3.96%)  23/425 (5.41%)  18/418 (4.31%) 
Psychiatric disorders       
Depression  1  25/429 (5.83%)  33/425 (7.76%)  28/418 (6.70%) 
Insomnia  1  16/429 (3.73%)  21/425 (4.94%)  25/418 (5.98%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  37/429 (8.62%)  43/425 (10.12%)  34/418 (8.13%) 
Dyspnoea  1  25/429 (5.83%)  30/425 (7.06%)  19/418 (4.55%) 
Oropharyngeal pain  1  17/429 (3.96%)  29/425 (6.82%)  29/418 (6.94%) 
Vascular disorders       
Hypertension  1  27/429 (6.29%)  26/425 (6.12%)  15/418 (3.59%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00289978     History of Changes
Other Study ID Numbers: CFTY720D2301
First Submitted: February 9, 2006
First Posted: February 10, 2006
Results First Submitted: January 4, 2011
Results First Posted: March 16, 2011
Last Update Posted: April 11, 2012