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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00289978
First received: February 9, 2006
Last updated: April 9, 2012
Last verified: April 2012
Results First Received: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Relapsing-remitting Multiple Sclerosis
Interventions: Drug: Fingolimod 1.25 mg
Drug: Fingolimod 0.5 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Patients self-administered a fingolimod placebo capsule orally once daily.

Participant Flow:   Overall Study
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo  
STARTED     429     425     418  
COMPLETED     332 [1]   369 [2]   332 [3]
NOT COMPLETED     97     56     86  
Withdrawal by Subject                 31                 17                 28  
Adverse Event                 22                 13                 18  
Lack of Efficacy                 13                 6                 25  
Abnormal laboratory value(s)                 20                 9                 1  
Lost to Follow-up                 3                 5                 7  
Protocol Violation                 5                 5                 4  
Abnormal test procedure result(s)                 2                 1                 1  
Death                 1                 0                 2  
[1] 296 completed on study drug, 35 completed off study drug.
[2] 345 completed on study drug, 24 completed off study drug.
[3] 303 completed on study drug, 29 completed off study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Patients self-administered a fingolimod placebo capsule orally once daily.
Total Total of all reporting groups

Baseline Measures
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo     Total  
Number of Participants  
[units: participants]
  429     425     418     1272  
Age  
[units: years]
Mean ± Standard Deviation
  37.4  ± 8.91     36.6  ± 8.77     37.2  ± 8.60     37.1  ± 8.76  
Age, Customized  
[units: participants]
       
<18 years     1     0     0     1  
18 -30     107     120     97     324  
31-40     147     162     165     474  
41-55     174     143     156     473  
Gender  
[units: participants]
       
Female     295     296     298     889  
Male     134     129     120     383  
Duration of multiple sclerosis since first symptoms  
[units: Years]
Mean ± Standard Deviation
  8.4  ± 6.86     8.0  ± 6.60     8.1  ± 6.35     8.2  ± 6.60  
Number of relapses in last 2 years  
[units: relapses]
Mean ± Standard Deviation
  1.5  ± 0.81     1.5  ± 0.76     1.4  ± 0.73     1.5  ± 0.77  
Expanded Disability Status Scale (EDSS) [1]
[units: Units on a scale]
Mean ± Standard Deviation
  2.41  ± 1.36     2.30  ± 1.29     2.49  ± 1.29     2.40  ± 1.32  
[1] The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel & bladder, cerebral, other functions). Based on scores in these 8 functional systems, an overall score ranging from 0 (normal) to 10 (death due to MS) is assigned. Patients with EDSS scores of 0.0 to 4.5 are fully ambulatory; patients with EDSS scores of 5.0 to 9.5 have impaired ambulation. EDSS was assessed by an evaluating physician at each site.



  Outcome Measures
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1.  Primary:   Estimated Annualized Aggregate Relapse Rate (ARR)   [ Time Frame: Baseline to end of study (Month 24) ]

2.  Secondary:   Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)   [ Time Frame: Baseline to end of study (Month 24) ]

3.  Secondary:   Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline   [ Time Frame: Baseline to end of study (Month 24) ]


  Serious Adverse Events
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Time Frame 24 Months
Additional Description Adverse events are reported based on the safety population. The safety population consists of all patients who received at least 1 dose of study drug.

Reporting Groups
  Description
Fingolimod 1.25 mg Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Fingolimod 0.5 mg Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Patients self-administered a fingolimod placebo capsule orally once daily.

Serious Adverse Events
    Fingolimod 1.25 mg     Fingolimod 0.5 mg     Placebo  
Total, serious adverse events        
# participants affected / at risk     51/429 (11.89%)     43/425 (10.12%)     56/418 (13.40%)  
Blood and lymphatic system disorders        
Leukopenia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Lymphopenia † 1      
# participants affected / at risk     2/429 (0.47%)     0/425 (0.00%)     0/418 (0.00%)  
Thrombocytopenia † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Cardiac disorders        
Angina pectoris † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Atrioventricular block first degree † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Atrioventricular block second degree † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Bradycardia † 1      
# participants affected / at risk     3/429 (0.70%)     4/425 (0.94%)     1/418 (0.24%)  
Left ventricular dysfunction † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Myocardial infarction † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     2/418 (0.48%)  
Palpitations † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Pericarditis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Supraventricular extrasystoles † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Tachycardia paroxysmal † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Ventricular tachycardia † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Eye disorders        
Eye pain † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Iridocyclitis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Keratitis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Macular oedema † 1      
# participants affected / at risk     3/429 (0.70%)     0/425 (0.00%)     0/418 (0.00%)  
Papilloedema † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Photopsia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Retinal detachment † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Retinal disorder † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Retinitis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Gastrointestinal disorders        
Abdominal pain † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     1/418 (0.24%)  
Abdominal pain upper † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Constipation † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Diarrhoea † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Dyspepsia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Gastritis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Haemorrhoids † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Ileus paralytic † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Inguinal hernia † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Oesophagitis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Pancreatitis chronic † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Vomiting † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     1/418 (0.24%)  
General disorders        
Chest pain † 1      
# participants affected / at risk     0/429 (0.00%)     2/425 (0.47%)     0/418 (0.00%)  
Fatigue † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Haemorrhagic cyst † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Inflammation † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Non-cardiac chest pain † 1      
# participants affected / at risk     0/429 (0.00%)     2/425 (0.47%)     2/418 (0.48%)  
Hepatobiliary disorders        
Biliary colic † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Cholelithiasis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Cytolytic hepatitis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Hepatic steatosis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Hepatomegaly † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Infections and infestations        
Abscess † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Abscess jaw † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Acute sinusitis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Anal abscess † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Appendicitis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Clostridial infection † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Cystitis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Dermo-hypodermitis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Gastroenteritis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     1/418 (0.24%)  
Genital herpes † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Herpes virus infection † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Mastoiditis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Otitis media acute † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Peritoneal abscess † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Peritonsillitis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Pharyngitis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     1/418 (0.24%)  
Pharyngotonsillitis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Pneumonia † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Pyelonephritis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Pyelonephritis acute † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Pyelonephritis chronic † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Respiratory tract infection † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Sinusitis † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Streptococcal abscess † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Tonsillitis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Tooth abscess † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Upper respiratory tract infection † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Urinary tract infection † 1      
# participants affected / at risk     0/429 (0.00%)     2/425 (0.47%)     0/418 (0.00%)  
Urosepsis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Injury, poisoning and procedural complications        
Burns second degree † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Fractured coccyx † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Head injury † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     1/418 (0.24%)  
Ligament rupture † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Lower limb fracture † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Overdose † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Road traffic accident † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Splenic injury † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Splenic rupture † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Subdural haematoma † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Investigations        
Alanine aminotransferase increased † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Aspartate aminotransferase increased † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Electrocardiogram PR prolongation † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Electrocardiogram change † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Gamma-glutamyltransferase increased † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Hepatic enzyme increased † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Liver function test abnormal † 1      
# participants affected / at risk     2/429 (0.47%)     0/425 (0.00%)     1/418 (0.24%)  
Precancerous cells present † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Red blood cell sedimentation rate increased † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Metabolism and nutrition disorders        
Dehydration † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Arthritis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Back pain † 1      
# participants affected / at risk     0/429 (0.00%)     2/425 (0.47%)     1/418 (0.24%)  
Bursitis † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Intervertebral disc protrusion † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     2/418 (0.48%)  
Myalgia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Pain in extremity † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Basal cell carcinoma † 1      
# participants affected / at risk     1/429 (0.23%)     4/425 (0.94%)     2/418 (0.48%)  
Benign ovarian tumour † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Bowen's disease † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Brain neoplasm benign † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Breast cancer † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     3/418 (0.72%)  
Cervix carcinoma stage 0 † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Endometrial cancer † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Malignant melanoma † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Ovarian adenoma † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Prostate cancer † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Uterine leiomyoma † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Nervous system disorders        
Amnesia † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Central nervous system lesion † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Cerebrovascular accident † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Epilepsy † 1      
# participants affected / at risk     2/429 (0.47%)     0/425 (0.00%)     0/418 (0.00%)  
Grand mal convulsion † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Headache † 1      
# participants affected / at risk     2/429 (0.47%)     0/425 (0.00%)     0/418 (0.00%)  
Ischaemic stroke † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Migraine with aura † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Monoplegia † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Multiple sclerosis † 1      
# participants affected / at risk     0/429 (0.00%)     2/425 (0.47%)     0/418 (0.00%)  
Multiple sclerosis relapse † 1      
# participants affected / at risk     3/429 (0.70%)     2/425 (0.47%)     1/418 (0.24%)  
Partial seizures with secondary generalisation † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Presyncope † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Sciatica † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Somnolence † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Syncope † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     1/418 (0.24%)  
Pregnancy, puerperium and perinatal conditions        
Abortion † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     3/418 (0.72%)  
Abortion spontaneous † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Psychiatric disorders        
Acute psychosis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Anxiety † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Depression † 1      
# participants affected / at risk     2/429 (0.47%)     0/425 (0.00%)     1/418 (0.24%)  
Homicidal ideation † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Renal and urinary disorders        
Nephrolithiasis † 1      
# participants affected / at risk     1/429 (0.23%)     1/425 (0.24%)     0/418 (0.00%)  
Renal colic † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Renal cyst † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Reproductive system and breast disorders        
Cervical dysplasia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Endometriosis † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Metrorrhagia † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     1/418 (0.24%)  
Ovarian cyst † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Ovarian disorder † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Asthma † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Chronic obstructive pulmonary disease † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Dyspnoea exertional † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Pleurisy † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Pneumonia aspiration † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Productive cough † 1      
# participants affected / at risk     1/429 (0.23%)     0/425 (0.00%)     0/418 (0.00%)  
Pulmonary embolism † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Pulmonary oedema † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Skin and subcutaneous tissue disorders        
Rash macular † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Urticaria † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Vascular disorders        
Circulatory collapse † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Hypertension † 1      
# participants affected / at risk     0/429 (0.00%)     0/425 (0.00%)     1/418 (0.24%)  
Varicose vein † 1      
# participants affected / at risk     0/429 (0.00%)     1/425 (0.24%)     0/418 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0




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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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