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Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy (EARLiMS)

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ClinicalTrials.gov Identifier: NCT01498887
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsing Remitting Multiple Sclerosis
Intervention Drug: Fingolimod (FTY720)
Enrollment 347
Recruitment Details  
Pre-assignment Details This was an open-label, non-randomized, parallel group study.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Period Title: Overall Study
Started 200 147
Safety Set 200 147
Intent-to-treat 185 135
Completed 184 136
Not Completed 16 11
Reason Not Completed
Administrative problems             1             0
Lost to Follow-up             1             1
Withdrawal by Subject             1             0
Protocol Violation             1             3
Lack of Efficacy             5             3
Abnormal result from test procedure             1             1
Abnormal laboratory value             2             2
Adverse Event             4             1
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants Total
Hide Arm/Group Description Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Total of all reporting groups
Overall Number of Baseline Participants 185 135 320
Hide Baseline Analysis Population Description
The analysis of the baseline characteristics was done on the ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 135 participants 320 participants
33.1  (8.08) 34.0  (7.44) 33.5  (7.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 135 participants 320 participants
Female
137
  74.1%
88
  65.2%
225
  70.3%
Male
48
  25.9%
47
  34.8%
95
  29.7%
1.Primary Outcome
Title Annual Relapse Rate (ARR)
Hide Description ARR = 365 days * number of relapses / total days taking the study medication.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 185 135
Mean (Standard Deviation)
Unit of Measure: Relapses per year
0.290  (0.7399) 0.354  (0.8547)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Naive or de Novo Participants, Previously Treated With First-line DMTs Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3118
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Time to First Relapse
Hide Description Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.
Time Frame first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 185 135
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Since less than half of the ITT population had a relapse, the median time since fingolimod treatment initiation to the first relapse was not reached.
3.Secondary Outcome
Title Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Hide Description The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population with both baseline and 12 month values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 182 130
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.000  (0.8040) -0.077  (0.7911)
4.Secondary Outcome
Title Change From Baseline in Cerebral Volume
Hide Description Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population with both baseline and 12 month values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 92 43
Mean (95% Confidence Interval)
Unit of Measure: Percent change
-0.595
(-0.759 to -0.431)
-0.387
(-0.583 to -0.191)
5.Secondary Outcome
Title Percentage of Participants With Mild, Moderate or Severe Relapse
Hide Description The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the ITT population with severity values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 47 39
Measure Type: Number
Unit of Measure: Percentage of participants
Mild 42.55 38.46
Moderate 57.45 56.41
Severe 0.00 5.13
6.Secondary Outcome
Title Percentage of Relapse-free Participants
Hide Description Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 185 135
Measure Type: Number
Unit of Measure: Percent
71.89 66.67
7.Secondary Outcome
Title Mean Number of T2 Active Lesions
Hide Description The mean number of new or enlarged T2 active lesions was assessed by MRI.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population with 12 month T2 lesion numbers were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants
Hide Arm/Group Description:
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Overall Number of Participants Analyzed 163 106
Mean (Standard Deviation)
Unit of Measure: T2 lesions
2.0  (3.36) 1.6  (2.72)
Time Frame Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, approximately 4 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Naive or de Novo Participants Previously Treated With First-line DMTs Participants All Participants
Hide Arm/Group Description Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. [Not Specified]
All-Cause Mortality
Naive or de Novo Participants Previously Treated With First-line DMTs Participants All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Naive or de Novo Participants Previously Treated With First-line DMTs Participants All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/200 (5.50%)   4/147 (2.72%)   15/347 (4.32%) 
Cardiac disorders       
Atrioventricular block  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Atrioventricular block second degree  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Bradycardia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Sinus bradycardia  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Hepatobiliary disorders       
Cholelithiasis  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Hepatitis acute  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Immune system disorders       
Drug hypersensitivity  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Infections and infestations       
Lower respiratory tract infection  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Diffuse large B-cell lymphoma  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Nervous system disorders       
Brain oedema  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Epilepsy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Multiple sclerosis relapse  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Partial seizures  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Reproductive system and breast disorders       
Ovarian cyst  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Naive or de Novo Participants Previously Treated With First-line DMTs Participants All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   143/200 (71.50%)   114/147 (77.55%)   257/347 (74.06%) 
Blood and lymphatic system disorders       
Anaemia  1  3/200 (1.50%)  0/147 (0.00%)  3/347 (0.86%) 
Iron deficiency anaemia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Lymphadenitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Lymphadenopathy  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Lymphocytosis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Lymphopenia  1  9/200 (4.50%)  7/147 (4.76%)  16/347 (4.61%) 
Microcytic anaemia  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Cardiac disorders       
Atrioventricular block first degree  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Bradycardia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Palpitations  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Tachycardia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Congenital, familial and genetic disorders       
Retinal anomaly congenital  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Ear and labyrinth disorders       
Cerumen impaction  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Ear pain  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Hypoacusis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Tinnitus  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Vertigo  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Eye disorders       
Amblyopia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Astigmatism  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Conjunctival haemorrhage  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Conjunctivitis  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Diplopia  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Dry eye  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Erythema of eyelid  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Eye pain  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Eyelid oedema  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Macular oedema  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Myopia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Ocular hyperaemia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Optic atrophy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pinguecula  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Presbyopia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Retinal pigment epitheliopathy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Strabismus  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Vision blurred  1  2/200 (1.00%)  3/147 (2.04%)  5/347 (1.44%) 
Visual impairment  1  2/200 (1.00%)  2/147 (1.36%)  4/347 (1.15%) 
Vitreous floaters  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Gastrointestinal disorders       
Abdominal discomfort  1  3/200 (1.50%)  1/147 (0.68%)  4/347 (1.15%) 
Abdominal distension  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Abdominal pain  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Abdominal pain upper  1  5/200 (2.50%)  3/147 (2.04%)  8/347 (2.31%) 
Constipation  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Dental caries  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Dental cyst  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Diarrhoea  1  5/200 (2.50%)  9/147 (6.12%)  14/347 (4.03%) 
Dyspepsia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Gastritis  1  3/200 (1.50%)  1/147 (0.68%)  4/347 (1.15%) 
Gastrointestinal motility disorder  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Gastrooesophageal reflux disease  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Gingival bleeding  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Haemorrhoids  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Hyperchlorhydria  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Mouth ulceration  1  4/200 (2.00%)  1/147 (0.68%)  5/347 (1.44%) 
Nausea  1  7/200 (3.50%)  5/147 (3.40%)  12/347 (3.46%) 
Odynophagia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Oesophagitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Oral discomfort  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Oral pain  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Stomatitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Toothache  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Vomiting  1  2/200 (1.00%)  4/147 (2.72%)  6/347 (1.73%) 
General disorders       
Adverse drug reaction  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Chest discomfort  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Chest pain  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Exercise tolerance decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Fatigue  1  11/200 (5.50%)  9/147 (6.12%)  20/347 (5.76%) 
Gait disturbance  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Influenza like illness  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Pain  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pyrexia  1  1/200 (0.50%)  5/147 (3.40%)  6/347 (1.73%) 
Hepatobiliary disorders       
Biliary colic  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hepatic function abnormal  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Hepatomegaly  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hypertransaminasaemia  1  3/200 (1.50%)  0/147 (0.00%)  3/347 (0.86%) 
Immune system disorders       
Hypersensitivity  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Infections and infestations       
Acute tonsillitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Bacterial vaginosis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Bronchitis  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Conjunctivitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Conjunctivitis viral  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Cystitis  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Ear infection  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Folliculitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Fungal skin infection  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Gastric infection  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Gastroenteritis  1  9/200 (4.50%)  6/147 (4.08%)  15/347 (4.32%) 
Gastroenteritis viral  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Genital herpes  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Genitourinary tract infection  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hand-foot-and-mouth disease  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Herpes ophthalmic  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Herpes simplex  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Herpes zoster  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Influenza  1  3/200 (1.50%)  3/147 (2.04%)  6/347 (1.73%) 
Laryngitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Lower respiratory tract infection  1  3/200 (1.50%)  0/147 (0.00%)  3/347 (0.86%) 
Molluscum contagiosum  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Nasopharyngitis  1  16/200 (8.00%)  8/147 (5.44%)  24/347 (6.92%) 
Onychomycosis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Ophthalmic herpes zoster  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Oral herpes  1  7/200 (3.50%)  5/147 (3.40%)  12/347 (3.46%) 
Paronychia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Periodontitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pertussis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pharyngitis  1  8/200 (4.00%)  4/147 (2.72%)  12/347 (3.46%) 
Pharyngitis bacterial  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Pharyngitis streptococcal  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pharyngotonsillitis  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Pneumonia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Respiratory tract infection  1  4/200 (2.00%)  2/147 (1.36%)  6/347 (1.73%) 
Rhinitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Sinusitis  1  3/200 (1.50%)  2/147 (1.36%)  5/347 (1.44%) 
Sinusitis bacterial  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Skin infection  1  0/200 (0.00%)  3/147 (2.04%)  3/347 (0.86%) 
Tinea versicolour  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Tonsillitis  1  6/200 (3.00%)  3/147 (2.04%)  9/347 (2.59%) 
Tonsillitis bacterial  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Tooth abscess  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Tooth infection  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Tracheobronchitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Upper respiratory tract infection  1  15/200 (7.50%)  12/147 (8.16%)  27/347 (7.78%) 
Urinary tract infection  1  15/200 (7.50%)  15/147 (10.20%)  30/347 (8.65%) 
Viral infection  1  3/200 (1.50%)  0/147 (0.00%)  3/347 (0.86%) 
Viral pharyngitis  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Vulvovaginal candidiasis  1  2/200 (1.00%)  5/147 (3.40%)  7/347 (2.02%) 
Vulvovaginal mycotic infection  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Wound infection bacterial  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Injury, poisoning and procedural complications       
Accident  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Contusion  1  3/200 (1.50%)  0/147 (0.00%)  3/347 (0.86%) 
Fall  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Foot fracture  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Ligament sprain  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Maternal exposure during pregnancy  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Muscle injury  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Road traffic accident  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Investigations       
Alanine aminotransferase increased  1  2/200 (1.00%)  5/147 (3.40%)  7/347 (2.02%) 
Aspartate aminotransferase increased  1  0/200 (0.00%)  5/147 (3.40%)  5/347 (1.44%) 
B-lymphocyte count decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Blood calcium decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Blood chloride increased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Blood cholesterol increased  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Blood iron decreased  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Blood pressure increased  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Blood triglycerides increased  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
CD4 lymphocytes decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
CD8 lymphocytes decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Electrocardiogram T wave abnormal  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Gamma-glutamyltransferase increased  1  0/200 (0.00%)  3/147 (2.04%)  3/347 (0.86%) 
Hepatic enzyme increased  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Liver function test abnormal  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Low density lipoprotein increased  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Lymphocyte count decreased  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Micturition urgency  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
T-lymphocyte count decreased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Transaminases abnormal  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Weight decreased  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Weight increased  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Metabolism and nutrition disorders       
Diabetes mellitus  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Dyslipidaemia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Hypercholesterolaemia  1  3/200 (1.50%)  4/147 (2.72%)  7/347 (2.02%) 
Hypertriglyceridaemia  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Hypocalcaemia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Hypokalaemia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Hypophosphataemia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Lactose intolerance  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Polydipsia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Vitamin D deficiency  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Back pain  1  12/200 (6.00%)  4/147 (2.72%)  16/347 (4.61%) 
Bursitis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Haemophilic arthropathy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Muscle contracture  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Muscle spasms  1  0/200 (0.00%)  3/147 (2.04%)  3/347 (0.86%) 
Muscular weakness  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Musculoskeletal pain  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Musculoskeletal stiffness  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Myokymia  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Neck pain  1  5/200 (2.50%)  6/147 (4.08%)  11/347 (3.17%) 
Pain in extremity  1  2/200 (1.00%)  2/147 (1.36%)  4/347 (1.15%) 
Sjogren's syndrome  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Spondylolisthesis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Synovial cyst  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Tendonitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Basal cell carcinoma  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Fibroadenoma of breast  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Fibrous histiocytoma  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Melanocytic naevus  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Seborrhoeic keratosis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Skin papilloma  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Superficial spreading melanoma stage unspecified  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Nervous system disorders       
Amnesia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Aphonia  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Balance disorder  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Burning sensation  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Carpal tunnel syndrome  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Cervicobrachial syndrome  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Dizziness  1  5/200 (2.50%)  7/147 (4.76%)  12/347 (3.46%) 
Dysaesthesia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Epilepsy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Head discomfort  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Headache  1  17/200 (8.50%)  17/147 (11.56%)  34/347 (9.80%) 
Hemiparesis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hyperreflexia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Hypersomnia  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hypoaesthesia  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Lethargy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Migraine  1  6/200 (3.00%)  6/147 (4.08%)  12/347 (3.46%) 
Migraine with aura  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Migraine without aura  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Multiple sclerosis relapse  1  2/200 (1.00%)  1/147 (0.68%)  3/347 (0.86%) 
Neuralgia  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Neurological symptom  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Neuropathy peripheral  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Optic neuritis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Paraesthesia  1  3/200 (1.50%)  4/147 (2.72%)  7/347 (2.02%) 
Partial seizures  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Presyncope  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Restless legs syndrome  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Sciatica  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Sensorimotor disorder  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Sleep paralysis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Somnolence  1  1/200 (0.50%)  2/147 (1.36%)  3/347 (0.86%) 
Syncope  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Tension headache  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Typical aura without headache  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Uhthoff's phenomenon  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
VIIth nerve paralysis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Psychiatric disorders       
Adjustment disorder with mixed anxiety and depressed mood  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Anxiety  1  11/200 (5.50%)  6/147 (4.08%)  17/347 (4.90%) 
Anxiety disorder  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Bruxism  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Confusional state  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Depressed mood  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Depression  1  9/200 (4.50%)  6/147 (4.08%)  15/347 (4.32%) 
Dysthymic disorder  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Generalised anxiety disorder  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Insomnia  1  5/200 (2.50%)  3/147 (2.04%)  8/347 (2.31%) 
Laziness  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Personality disorder  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Renal and urinary disorders       
Dysuria  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Lower urinary tract symptoms  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Micturition urgency  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Neurogenic bladder  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Pollakiuria  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Polyuria  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Renal colic  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Renal pain  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Urinary incontinence  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Urinary retention  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Reproductive system and breast disorders       
Amenorrhoea  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Benign prostatic hyperplasia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Cervical dysplasia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Dysmenorrhoea  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Erectile dysfunction  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Menorrhagia  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Menstrual disorder  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Metrorrhagia  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Sexual dysfunction  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/200 (0.50%)  4/147 (2.72%)  5/347 (1.44%) 
Dyspnoea  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Epistaxis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Nasal dryness  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Oropharyngeal pain  1  3/200 (1.50%)  1/147 (0.68%)  4/347 (1.15%) 
Skin and subcutaneous tissue disorders       
Acne  1  3/200 (1.50%)  2/147 (1.36%)  5/347 (1.44%) 
Actinic keratosis  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Alopecia  1  4/200 (2.00%)  3/147 (2.04%)  7/347 (2.02%) 
Dermatitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Dermatitis allergic  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Dermatitis atopic  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Eczema  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Eczema nummular  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Erythema  1  0/200 (0.00%)  2/147 (1.36%)  2/347 (0.58%) 
Hand dermatitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hidradenitis  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hyperhidrosis  1  2/200 (1.00%)  0/147 (0.00%)  2/347 (0.58%) 
Night sweats  1  1/200 (0.50%)  1/147 (0.68%)  2/347 (0.58%) 
Pain of skin  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Rash  1  4/200 (2.00%)  0/147 (0.00%)  4/347 (1.15%) 
Rash macular  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Rash pruritic  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Seborrhoeic dermatitis  1  2/200 (1.00%)  2/147 (1.36%)  4/347 (1.15%) 
Skin depigmentation  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Skin discolouration  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Skin fissures  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Skin hypertrophy  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Skin lesion  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Solar lentigo  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Surgical and medical procedures       
Intraocular lens implant  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Skin lesion excision  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Tooth extraction  1  1/200 (0.50%)  0/147 (0.00%)  1/347 (0.29%) 
Vascular disorders       
Flushing  1  0/200 (0.00%)  1/147 (0.68%)  1/347 (0.29%) 
Hypertension  1  1/200 (0.50%)  3/147 (2.04%)  4/347 (1.15%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.0)
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 or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01498887     History of Changes
Other Study ID Numbers: CFTY720DES03
2011-003484-30 ( EudraCT Number )
First Submitted: December 19, 2011
First Posted: December 26, 2011
Results First Submitted: October 25, 2017
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019