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Trial record 15 of 10804 for:    Placebo AND once

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

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ClinicalTrials.gov Identifier: NCT01625182
Recruitment Status : Completed
First Posted : June 21, 2012
Results First Posted : September 19, 2017
Last Update Posted : October 30, 2017
Sponsor:
Collaborator:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions Drug: Fingolimod
Drug: Placebo Comparator
Enrollment 106
Recruitment Details  
Pre-assignment Details Participants were assigned randomly to each treatment group in a 1:1 ratio.
Arm/Group Title Fingolimod (FTY720) Placebo
Hide Arm/Group Description Participants received Fingolimod 0.5 mg orally once daily. Participants received matching placebo to Fingolimod orally once daily.
Period Title: Overall Study
Started 54 52
Completed 34 41
Not Completed 20 11
Reason Not Completed
Administrative problems             1             0
Protocol deviation             0             2
Adverse Event             2             0
Withdrawal by Subject             5             1
Lack of Efficacy             12             8
Arm/Group Title Fingolimod (FTY720) Placebo Total
Hide Arm/Group Description Participants received Fingolimod 0.5 mg orally once daily. Participants received matching placebo to Fingolimod orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 54 52 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 52 participants 106 participants
54.3  (13.32) 54.6  (11.68) 54.5  (12.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
Female
17
  31.5%
22
  42.3%
39
  36.8%
Male
37
  68.5%
30
  57.7%
67
  63.2%
1.Primary Outcome
Title Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale
Hide Description Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.
Arm/Group Title Fingolimod (FTY720) Placebo
Hide Arm/Group Description:
Participants received Fingolimod 0.5 mg orally once daily.
Participants received matching placebo to Fingolimod orally once daily.
Overall Number of Participants Analyzed 54 52
Median (95% Confidence Interval)
Unit of Measure: Days
721.0 [1] 
(159.0 to NA)
540.0 [1] 
(183.0 to NA)
[1]
The 95% upper confidence interval not estimable.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fingolimod (FTY720), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9838
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.6 to 1.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline for Grip Strength, Dominant Hand
Hide Description Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time Frame baseline, Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.
Arm/Group Title Fingolimod (FTY720) Placebo
Hide Arm/Group Description:
Participants received Fingolimod 0.5 mg orally once daily.
Participants received matching placebo to Fingolimod orally once daily.
Overall Number of Participants Analyzed 53 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kPa
Month 6
-2.6
(-8.09 to 2.80)
-3.8
(-9.37 to 1.70)
Month 12
-0.8
(-6.47 to 4.96)
-3.9
(-9.68 to 1.94)
3.Secondary Outcome
Title Change From Baseline for Grip Strength, Non-dominant Hand
Hide Description Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.
Time Frame baseline, Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.
Arm/Group Title Fingolimod (FTY720) Placebo
Hide Arm/Group Description:
Participants received Fingolimod 0.5 mg orally once daily.
Participants received matching placebo to Fingolimod orally once daily.
Overall Number of Participants Analyzed 53 50
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kPa
Month 6
-2.7
(-8.13 to 2.66)
-6.1
(-11.59 to -0.66)
Month 12
-1.2
(-6.69 to 4.37)
-5.0
(-10.57 to 0.64)
4.Secondary Outcome
Title Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
Hide Description This questionnaire was constructed using the patients’ perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.
Time Frame baseline, Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.
Arm/Group Title Fingolimod (FTY720) Placebo
Hide Arm/Group Description:
Participants received Fingolimod 0.5 mg orally once daily.
Participants received matching placebo to Fingolimod orally once daily.
Overall Number of Participants Analyzed 54 51
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Month 6
-6.4
(-9.57 to -3.15)
-5.5
(-8.89 to -2.21)
Month 12
-5.7
(-9.07 to -2.37)
-5.1
(-8.54 to -1.57)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fingolimod (FTY720) Placebo Overall Participants
Hide Arm/Group Description Participants received Fingolimod 0.5 mg orally once daily. Participants received matching placebo to Fingolimod orally once daily. [Not Specified]
All-Cause Mortality
Fingolimod (FTY720) Placebo Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fingolimod (FTY720) Placebo Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/54 (16.67%)   4/52 (7.69%)   13/106 (12.26%) 
General disorders       
Oedema peripheral  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Infections and infestations       
Abdominal sepsis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Cellulitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications       
Ankle fracture  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders       
Bursitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Breast cancer  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Gastric cancer  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Retroperitoneal cancer  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Nervous system disorders       
Cauda equina syndrome  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Chronic inflammatory demyelinating polyradiculoneuropathy  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Guillain-Barre syndrome  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Vascular disorders       
Vasculitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.0%
Fingolimod (FTY720) Placebo Overall Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/54 (74.07%)   42/52 (80.77%)   82/106 (77.36%) 
Blood and lymphatic system disorders       
Anaemia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Leukopenia  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Cardiac disorders       
Palpitations  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Tachycardia  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Congenital, familial and genetic disorders       
Ventricular septal defect  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Ear and labyrinth disorders       
Ear pain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tinnitus  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Vertigo  1  3/54 (5.56%)  3/52 (5.77%)  6/106 (5.66%) 
Endocrine disorders       
Cushingoid  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Hypothyroidism  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Eye disorders       
Blepharitis  1  2/54 (3.70%)  0/52 (0.00%)  2/106 (1.89%) 
Cataract  1  1/54 (1.85%)  3/52 (5.77%)  4/106 (3.77%) 
Diplopia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Eye pain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Eye pruritus  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Iritis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Macular oedema  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Meibomianitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Metamorphopsia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Retinal disorder  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Retinoschisis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Subretinal fluid  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Vision blurred  1  2/54 (3.70%)  0/52 (0.00%)  2/106 (1.89%) 
Visual acuity reduced  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Visual impairment  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Vitreous detachment  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Vitreous floaters  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Abdominal distension  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Abdominal mass  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Abdominal pain  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Abdominal pain upper  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Change of bowel habit  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Chronic gastritis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Constipation  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Diarrhoea  1  3/54 (5.56%)  2/52 (3.85%)  5/106 (4.72%) 
Dry mouth  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dyspepsia  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Dysphagia  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Food poisoning  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Gastrointestinal disorder  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Gastrooesophageal reflux disease  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Gingival cyst  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Gingival hyperplasia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Nausea  1  2/54 (3.70%)  6/52 (11.54%)  8/106 (7.55%) 
Oesophagitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Periodontal disease  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Tooth disorder  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Tooth loss  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
General disorders       
Adverse drug reaction  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Asthenia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Chest discomfort  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Discomfort  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Fatigue  1  4/54 (7.41%)  6/52 (11.54%)  10/106 (9.43%) 
Influenza like illness  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Local swelling  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Oedema peripheral  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Pain  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Peripheral swelling  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Pyrexia  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Hepatobiliary disorders       
Hepatic function abnormal  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Liver disorder  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Immune system disorders       
Drug hypersensitivity  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Infections and infestations       
Bronchitis  1  3/54 (5.56%)  1/52 (1.92%)  4/106 (3.77%) 
Candida infection  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Catheter site infection  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Diverticulitis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Ear infection  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Folliculitis  1  2/54 (3.70%)  3/52 (5.77%)  5/106 (4.72%) 
Gastroenteritis  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Gastroenteritis viral  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Herpes zoster  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Influenza  1  2/54 (3.70%)  0/52 (0.00%)  2/106 (1.89%) 
Laryngitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Meningitis aseptic  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Nasopharyngitis  1  6/54 (11.11%)  7/52 (13.46%)  13/106 (12.26%) 
Onychomycosis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Oral herpes  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Parasitic gastroenteritis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Periodontitis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Pharyngitis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Pharyngotonsillitis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Sinusitis  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Tinea cruris  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Tinea infection  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tonsillitis bacterial  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tooth infection  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Upper respiratory tract infection  1  1/54 (1.85%)  2/52 (3.85%)  3/106 (2.83%) 
Urinary tract infection  1  3/54 (5.56%)  1/52 (1.92%)  4/106 (3.77%) 
Vulvovaginal candidiasis  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Wound infection  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications       
Back injury  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Concussion  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Excoriation  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Fall  1  4/54 (7.41%)  1/52 (1.92%)  5/106 (4.72%) 
Foot fracture  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Hand fracture  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Infusion related reaction  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Joint dislocation  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Joint injury  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Ligament sprain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Limb injury  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Muscle hernia  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Muscle strain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Post-traumatic pain  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Procedural headache  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Procedural pain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tooth fracture  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Wound  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Wrist fracture  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Investigations       
Alanine aminotransferase increased  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Amylase increased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Aspartate aminotransferase increased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Blood alkaline phosphatase increased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Blood cholesterol increased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Blood urine present  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Carbon monoxide diffusing capacity decreased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Cardiac murmur  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Gamma-glutamyltransferase increased  1  3/54 (5.56%)  0/52 (0.00%)  3/106 (2.83%) 
Glycosylated haemoglobin increased  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Grip strength decreased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Heart rate increased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Hepatic enzyme increased  1  2/54 (3.70%)  0/52 (0.00%)  2/106 (1.89%) 
Hepatitis A virus test positive  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Occult blood  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Optic nerve cup/disc ratio increased  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Pulmonary function test decreased  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Serum ferritin decreased  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dyslipidaemia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Fluid retention  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Hypercholesterolaemia  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Increased appetite  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Vitamin D deficiency  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/54 (1.85%)  2/52 (3.85%)  3/106 (2.83%) 
Arthritis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Arthropathy  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Back pain  1  4/54 (7.41%)  3/52 (5.77%)  7/106 (6.60%) 
Bursitis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Exostosis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Joint swelling  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Monarthritis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Muscle spasms  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Muscle twitching  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Muscular weakness  1  2/54 (3.70%)  2/52 (3.85%)  4/106 (3.77%) 
Musculoskeletal pain  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Musculoskeletal stiffness  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Myalgia  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Neck mass  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Neck pain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Osteoarthritis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Pain in extremity  1  7/54 (12.96%)  3/52 (5.77%)  10/106 (9.43%) 
Rheumatoid arthritis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Spinal column stenosis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Synovial cyst  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tendon pain  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Tendonitis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Torticollis  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Acrochordon  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Fibrous histiocytoma  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Haemangioma  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Haemangioma of skin  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Malignant melanoma in situ  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Melanocytic naevus  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Seborrhoeic keratosis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Skin papilloma  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Uterine leiomyoma  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Nervous system disorders       
Amnesia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Coordination abnormal  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Dizziness  1  3/54 (5.56%)  2/52 (3.85%)  5/106 (4.72%) 
Dysgeusia  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Headache  1  12/54 (22.22%)  8/52 (15.38%)  20/106 (18.87%) 
Hypoaesthesia  1  2/54 (3.70%)  2/52 (3.85%)  4/106 (3.77%) 
Memory impairment  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Meningism  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Migraine  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Neuralgia  1  0/54 (0.00%)  2/52 (3.85%)  2/106 (1.89%) 
Neuropathy peripheral  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Paraesthesia  1  5/54 (9.26%)  0/52 (0.00%)  5/106 (4.72%) 
Parkinsonism  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Sciatica  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Somnolence  1  1/54 (1.85%)  2/52 (3.85%)  3/106 (2.83%) 
Syncope  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Tremor  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Psychiatric disorders       
Abnormal dreams  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Anxiety  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Hallucination  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Insomnia  1  1/54 (1.85%)  4/52 (7.69%)  5/106 (4.72%) 
Irritability  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Renal and urinary disorders       
Cystitis noninfective  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dysuria  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Urinary tract inflammation  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Reproductive system and breast disorders       
Breast cyst  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Breast pain  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Breast swelling  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dysfunctional uterine bleeding  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Respiratory, thoracic and mediastinal disorders       
Bronchial obstruction  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Cough  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Dyspnoea  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Dyspnoea exertional  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Epistaxis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Nasal congestion  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Oropharyngeal pain  1  1/54 (1.85%)  3/52 (5.77%)  4/106 (3.77%) 
Rhinitis allergic  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Rhinorrhoea  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Skin and subcutaneous tissue disorders       
Actinic keratosis  1  1/54 (1.85%)  3/52 (5.77%)  4/106 (3.77%) 
Alopecia  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Chloasma  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dermatitis  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Dermatitis allergic  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Dermatitis contact  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Dry skin  1  1/54 (1.85%)  2/52 (3.85%)  3/106 (2.83%) 
Eczema  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Erythema  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Idiopathic urticaria  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Ingrowing nail  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Intertrigo  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Lentigo  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Night sweats  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Onycholysis  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Petechiae  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Pityriasis rosea  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Pruritus  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Rash  1  2/54 (3.70%)  3/52 (5.77%)  5/106 (4.72%) 
Rash erythematous  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Rash generalised  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Rash pruritic  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Rosacea  1  1/54 (1.85%)  1/52 (1.92%)  2/106 (1.89%) 
Seborrhoeic dermatitis  1  0/54 (0.00%)  3/52 (5.77%)  3/106 (2.83%) 
Skin fissures  1  1/54 (1.85%)  0/52 (0.00%)  1/106 (0.94%) 
Skin lesion  1  2/54 (3.70%)  2/52 (3.85%)  4/106 (3.77%) 
Urticaria  1  2/54 (3.70%)  1/52 (1.92%)  3/106 (2.83%) 
Vascular disorders       
Hot flush  1  0/54 (0.00%)  1/52 (1.92%)  1/106 (0.94%) 
Hypertension  1  10/54 (18.52%)  1/52 (1.92%)  11/106 (10.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
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
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01625182     History of Changes
Other Study ID Numbers: CFTY720I2201
2011-005280-24 ( EudraCT Number )
First Submitted: June 19, 2012
First Posted: June 21, 2012
Results First Submitted: August 17, 2017
Results First Posted: September 19, 2017
Last Update Posted: October 30, 2017