Trial Outcomes & Findings for Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients. (NCT NCT01625182)
NCT ID: NCT01625182
Last Updated: 2017-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
Month 12
Results posted on
2017-10-30
Participant Flow
Participants were assigned randomly to each treatment group in a 1:1 ratio.
Participant milestones
| Measure |
Fingolimod (FTY720)
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
52
|
|
Overall Study
COMPLETED
|
34
|
41
|
|
Overall Study
NOT COMPLETED
|
20
|
11
|
Reasons for withdrawal
| Measure |
Fingolimod (FTY720)
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Overall Study
Administrative problems
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Lack of Efficacy
|
12
|
8
|
Baseline Characteristics
Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.
Baseline characteristics by cohort
| Measure |
Fingolimod (FTY720)
n=54 Participants
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=52 Participants
Participants received matching placebo to Fingolimod orally once daily.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.3 Years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
54.6 Years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
54.5 Years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.
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.
Outcome measures
| Measure |
Fingolimod (FTY720)
n=54 Participants
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=52 Participants
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale
|
721.0 Days
Interval 159.0 to
The 95% upper confidence interval not estimable.
|
540.0 Days
Interval 183.0 to
The 95% upper confidence interval not estimable.
|
SECONDARY outcome
Timeframe: baseline, Month 6, Month 12Population: 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.
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.
Outcome measures
| Measure |
Fingolimod (FTY720)
n=53 Participants
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=50 Participants
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Change From Baseline for Grip Strength, Dominant Hand
Month 6
|
-2.6 kPa
Interval -8.09 to 2.8
|
-3.8 kPa
Interval -9.37 to 1.7
|
|
Change From Baseline for Grip Strength, Dominant Hand
Month 12
|
-0.8 kPa
Interval -6.47 to 4.96
|
-3.9 kPa
Interval -9.68 to 1.94
|
SECONDARY outcome
Timeframe: baseline, Month 6, Month 12Population: 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.
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.
Outcome measures
| Measure |
Fingolimod (FTY720)
n=53 Participants
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=50 Participants
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Change From Baseline for Grip Strength, Non-dominant Hand
Month 6
|
-2.7 kPa
Interval -8.13 to 2.66
|
-6.1 kPa
Interval -11.59 to -0.66
|
|
Change From Baseline for Grip Strength, Non-dominant Hand
Month 12
|
-1.2 kPa
Interval -6.69 to 4.37
|
-5.0 kPa
Interval -10.57 to 0.64
|
SECONDARY outcome
Timeframe: baseline, Month 6, Month 12Population: 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.
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.
Outcome measures
| Measure |
Fingolimod (FTY720)
n=54 Participants
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=51 Participants
Participants received matching placebo to Fingolimod orally once daily.
|
|---|---|---|
|
Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
Month 6
|
-6.4 score on a scale
Interval -9.57 to -3.15
|
-5.5 score on a scale
Interval -8.89 to -2.21
|
|
Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)
Month 12
|
-5.7 score on a scale
Interval -9.07 to -2.37
|
-5.1 score on a scale
Interval -8.54 to -1.57
|
Adverse Events
Fingolimod (FTY720)
Serious events: 9 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 42 other events
Deaths: 0 deaths
Overall Participants
Serious events: 13 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fingolimod (FTY720)
n=54 participants at risk
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=52 participants at risk
Participants received matching placebo to Fingolimod orally once daily.
|
Overall Participants
n=106 participants at risk
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Abdominal sepsis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Cellulitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal cancer
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Nervous system disorders
Guillain-Barre syndrome
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Vascular disorders
Vasculitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
Other adverse events
| Measure |
Fingolimod (FTY720)
n=54 participants at risk
Participants received Fingolimod 0.5 mg orally once daily.
|
Placebo
n=52 participants at risk
Participants received matching placebo to Fingolimod orally once daily.
|
Overall Participants
n=106 participants at risk
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Idiopathic urticaria
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Cardiac disorders
Palpitations
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Ear and labyrinth disorders
Ear pain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Ear and labyrinth disorders
Tinnitus
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
3/54
|
5.8%
3/52
|
5.7%
6/106
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Endocrine disorders
Hypothyroidism
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Blepharitis
|
3.7%
2/54
|
0.00%
0/52
|
1.9%
2/106
|
|
Eye disorders
Cataract
|
1.9%
1/54
|
5.8%
3/52
|
3.8%
4/106
|
|
Eye disorders
Diplopia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Eye pain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Eye pruritus
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Iritis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Macular oedema
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Eye disorders
Meibomianitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Metamorphopsia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Retinal disorder
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Retinoschisis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Eye disorders
Vision blurred
|
3.7%
2/54
|
0.00%
0/52
|
1.9%
2/106
|
|
Eye disorders
Visual acuity reduced
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Visual impairment
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Eye disorders
Vitreous detachment
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Eye disorders
Vitreous floaters
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal mass
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Gastrointestinal disorders
Change of bowel habit
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Constipation
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
3/54
|
3.8%
2/52
|
4.7%
5/106
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Gingival cyst
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54
|
11.5%
6/52
|
7.5%
8/106
|
|
Gastrointestinal disorders
Oesophagitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Gastrointestinal disorders
Tooth loss
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
General disorders
Adverse drug reaction
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
General disorders
Asthenia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
General disorders
Chest discomfort
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
General disorders
Discomfort
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
General disorders
Fatigue
|
7.4%
4/54
|
11.5%
6/52
|
9.4%
10/106
|
|
General disorders
Influenza like illness
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
General disorders
Local swelling
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
General disorders
Oedema peripheral
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
General disorders
Pain
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
General disorders
Peripheral swelling
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
General disorders
Pyrexia
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Hepatobiliary disorders
Liver disorder
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Bronchitis
|
5.6%
3/54
|
1.9%
1/52
|
3.8%
4/106
|
|
Infections and infestations
Candida infection
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Ear infection
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Folliculitis
|
3.7%
2/54
|
5.8%
3/52
|
4.7%
5/106
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Infections and infestations
Herpes zoster
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Infections and infestations
Influenza
|
3.7%
2/54
|
0.00%
0/52
|
1.9%
2/106
|
|
Infections and infestations
Laryngitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
6/54
|
13.5%
7/52
|
12.3%
13/106
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Oral herpes
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Periodontitis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Pharyngotonsillitis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Sinusitis
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Infections and infestations
Tinea infection
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Tonsillitis bacterial
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Infections and infestations
Tooth infection
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/54
|
3.8%
2/52
|
2.8%
3/106
|
|
Infections and infestations
Urinary tract infection
|
5.6%
3/54
|
1.9%
1/52
|
3.8%
4/106
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Infections and infestations
Wound infection
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Back injury
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Fall
|
7.4%
4/54
|
1.9%
1/52
|
4.7%
5/106
|
|
Injury, poisoning and procedural complications
Foot fracture
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Joint injury
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Muscle hernia
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Wound
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Investigations
Amylase increased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Aspartate aminotransferase increased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Blood alkaline phosphatase increased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Blood cholesterol increased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Blood urine present
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Cardiac murmur
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.6%
3/54
|
0.00%
0/52
|
2.8%
3/106
|
|
Investigations
Glycosylated haemoglobin increased
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Investigations
Grip strength decreased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Heart rate increased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Hepatic enzyme increased
|
3.7%
2/54
|
0.00%
0/52
|
1.9%
2/106
|
|
Investigations
Hepatitis A virus test positive
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Investigations
Occult blood
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Investigations
Optic nerve cup/disc ratio increased
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Investigations
Pulmonary function test decreased
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Investigations
Serum ferritin decreased
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54
|
3.8%
2/52
|
2.8%
3/106
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
4/54
|
5.8%
3/52
|
6.6%
7/106
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.7%
2/54
|
3.8%
2/52
|
3.8%
4/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
7/54
|
5.8%
3/52
|
9.4%
10/106
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Nervous system disorders
Amnesia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Nervous system disorders
Coordination abnormal
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Nervous system disorders
Dizziness
|
5.6%
3/54
|
3.8%
2/52
|
4.7%
5/106
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Nervous system disorders
Headache
|
22.2%
12/54
|
15.4%
8/52
|
18.9%
20/106
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
2/54
|
3.8%
2/52
|
3.8%
4/106
|
|
Nervous system disorders
Memory impairment
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Nervous system disorders
Meningism
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Nervous system disorders
Migraine
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/54
|
3.8%
2/52
|
1.9%
2/106
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Nervous system disorders
Paraesthesia
|
9.3%
5/54
|
0.00%
0/52
|
4.7%
5/106
|
|
Nervous system disorders
Parkinsonism
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Nervous system disorders
Sciatica
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Nervous system disorders
Somnolence
|
1.9%
1/54
|
3.8%
2/52
|
2.8%
3/106
|
|
Nervous system disorders
Syncope
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Nervous system disorders
Tremor
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Psychiatric disorders
Anxiety
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Psychiatric disorders
Hallucination
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/54
|
7.7%
4/52
|
4.7%
5/106
|
|
Psychiatric disorders
Irritability
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Renal and urinary disorders
Urinary tract inflammation
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Breast cyst
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/54
|
5.8%
3/52
|
3.8%
4/106
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.9%
1/54
|
5.8%
3/52
|
3.8%
4/106
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Skin and subcutaneous tissue disorders
Chloasma
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.9%
1/54
|
3.8%
2/52
|
2.8%
3/106
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Pityriasis rosea
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
2/54
|
5.8%
3/52
|
4.7%
5/106
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
1.9%
1/54
|
1.9%
1/52
|
1.9%
2/106
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/54
|
5.8%
3/52
|
2.8%
3/106
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
1.9%
1/54
|
0.00%
0/52
|
0.94%
1/106
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
3.7%
2/54
|
3.8%
2/52
|
3.8%
4/106
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.7%
2/54
|
1.9%
1/52
|
2.8%
3/106
|
|
Vascular disorders
Hot flush
|
0.00%
0/54
|
1.9%
1/52
|
0.94%
1/106
|
|
Vascular disorders
Hypertension
|
18.5%
10/54
|
1.9%
1/52
|
10.4%
11/106
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER