Non-serious adverse events
|
Fingolimod 0.5 mg |
Total subjects affected by non serious adverse events
|
|
subjects affected / exposed
|
2179 / 6998 (31.14%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
Basal cell carcinoma
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pharyngeal neoplasm benign
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vascular disorders
|
|
Blood pressure fluctuation
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Circulatory collapse
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Diastolic hypertension
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Flushing
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Haematoma
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hot flush
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Hypertension
|
|
subjects affected / exposed
|
64 / 6998 (0.91%) |
occurrences all number
|
64 |
Hypotension
|
|
subjects affected / exposed
|
12 / 6998 (0.17%) |
occurrences all number
|
12 |
Pallor
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Peripheral coldness
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Varicose vein
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pregnancy, puerperium and perinatal conditions
|
|
Pregnancy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pregnancy of unknown location
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Unintended pregnancy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
General disorders and administration site conditions
|
|
Application site reaction
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Asthenia
|
|
subjects affected / exposed
|
10 / 6998 (0.14%) |
occurrences all number
|
10 |
Chest discomfort
|
|
subjects affected / exposed
|
24 / 6998 (0.34%) |
occurrences all number
|
25 |
Chest pain
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Chills
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Chronic fatigue syndrome
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Discomfort
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Face oedema
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Fatigue
|
|
subjects affected / exposed
|
227 / 6998 (3.24%) |
occurrences all number
|
227 |
Feeling abnormal
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Feeling cold
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
8 |
Feeling drunk
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Feeling hot
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Gait disturbance
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Inflammation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Influenza like illness
|
|
subjects affected / exposed
|
19 / 6998 (0.27%) |
occurrences all number
|
19 |
Infusion site inflammation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Infusion site necrosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Local swelling
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Malaise
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Mucosal dryness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Non-cardiac chest pain
|
|
subjects affected / exposed
|
31 / 6998 (0.44%) |
occurrences all number
|
31 |
Oedema peripheral
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Peripheral swelling
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pyrexia
|
|
subjects affected / exposed
|
17 / 6998 (0.24%) |
occurrences all number
|
17 |
Secretion discharge
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sensation of foreign body
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sense of oppression
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Temperature intolerance
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Thirst
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Immune system disorders
|
|
Food allergy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hypersensitivity
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Seasonal allergy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Social circumstances
|
|
Walking disability
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Reproductive system and breast disorders
|
|
Breast discomfort
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Breast disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Breast pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
3 |
Breast tenderness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Cervical dysplasia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dysmenorrhoea
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Metrorrhagia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Ovulation pain
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Priapism
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Uterine haemorrhage
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vulvovaginal burning sensation
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Respiratory, thoracic and mediastinal disorders
|
|
Allergic bronchitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Asthma
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Cough
|
|
subjects affected / exposed
|
20 / 6998 (0.29%) |
occurrences all number
|
20 |
Dysphonia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dyspnoea
|
|
subjects affected / exposed
|
18 / 6998 (0.26%) |
occurrences all number
|
18 |
Dyspnoea exertional
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Epistaxis
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Increased bronchial secretion
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Nasal congestion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nasal oedema
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Oropharyngeal pain
|
|
subjects affected / exposed
|
27 / 6998 (0.39%) |
occurrences all number
|
27 |
Painful respiration
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pleurisy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Respiratory distress
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Rhinitis allergic
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Rhinorrhoea
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Sinus disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Throat irritation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Throat tightness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Psychiatric disorders
|
|
Adjustment disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Adjustment disorder with depressed mood
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Affective disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Aggression
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Agitation
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Anxiety
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Depressed mood
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Depression
|
|
subjects affected / exposed
|
19 / 6998 (0.27%) |
occurrences all number
|
19 |
Dyssomnia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Emotional disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Initial insomnia
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Insomnia
|
|
subjects affected / exposed
|
12 / 6998 (0.17%) |
occurrences all number
|
12 |
Irritability
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Laziness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Listless
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Mental disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Mental fatigue
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Middle insomnia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Mood altered
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Mood swings
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Nervousness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nightmare
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Panic attack
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Persistent depressive disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Restlessness
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
8 |
Sleep disorder
|
|
subjects affected / exposed
|
18 / 6998 (0.26%) |
occurrences all number
|
18 |
Product issues
|
|
Device defective
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hepatobiliary disorders
|
|
Hepatic steatosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hyperbilirubinaemia
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Liver disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Investigations
|
|
Alanine aminotransferase increased
|
|
subjects affected / exposed
|
21 / 6998 (0.30%) |
occurrences all number
|
21 |
Aspartate aminotransferase increased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Basophil count increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Blood alkaline phosphatase increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Blood bilirubin increased
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Blood chloride decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Blood creatinine increased
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Blood glucose decreased
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Blood glucose increased
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
10 |
Blood pressure decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Blood pressure diastolic decreased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Blood pressure diastolic increased
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Blood pressure increased
|
|
subjects affected / exposed
|
10 / 6998 (0.14%) |
occurrences all number
|
10 |
Blood pressure systolic increased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Blood urea increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Body temperature increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Electrocardiogram P wave abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Electrocardiogram QRS complex prolonged
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Electrocardiogram QT prolonged
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Electrocardiogram ST segment abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Electrocardiogram ST segment depression
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Electrocardiogram T wave inversion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Electrocardiogram abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Eosinophil count decreased
|
|
subjects affected / exposed
|
13 / 6998 (0.19%) |
occurrences all number
|
13 |
Eosinophil count increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gamma-glutamyltransferase increased
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
9 |
Haematocrit decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Haematocrit increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Haemoglobin decreased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Haemoglobin increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Heart rate abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Heart rate decreased
|
|
subjects affected / exposed
|
13 / 6998 (0.19%) |
occurrences all number
|
13 |
Heart rate increased
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Hepatic enzyme increased
|
|
subjects affected / exposed
|
14 / 6998 (0.20%) |
occurrences all number
|
14 |
Liver function test increased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Lymphocyte count abnormal
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Lymphocyte count decreased
|
|
subjects affected / exposed
|
36 / 6998 (0.51%) |
occurrences all number
|
36 |
Lymphocyte count increased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Monocyte count decreased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Monocyte count increased
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Neutrophil count decreased
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Neutrophil count increased
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Platelet aggregation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Platelet count decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pulse abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Red blood cell count decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Transaminases increased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Weight decreased
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Weight increased
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
White blood cell count decreased
|
|
subjects affected / exposed
|
18 / 6998 (0.26%) |
occurrences all number
|
18 |
White blood cell count increased
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
White blood cells urine
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Injury, poisoning and procedural complications
|
|
Animal bite
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Animal scratch
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Chest injury
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Fall
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Foot fracture
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Laceration
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Ligament sprain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Limb injury
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Meniscus injury
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Post procedural complication
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Skin abrasion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Thermal burn
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Congenital, familial and genetic disorders
|
|
Corneal dystrophy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Cardiac disorders
|
|
Angina pectoris
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Arrhythmia
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Atrioventricular block first degree
|
|
subjects affected / exposed
|
116 / 6998 (1.66%) |
occurrences all number
|
117 |
Atrioventricular block second degree
|
|
subjects affected / exposed
|
74 / 6998 (1.06%) |
occurrences all number
|
74 |
Bradycardia
|
|
subjects affected / exposed
|
48 / 6998 (0.69%) |
occurrences all number
|
48 |
Bundle branch block right
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Cardiac discomfort
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Cardiovascular disorder
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Coronary artery stenosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Extrasystoles
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Palpitations
|
|
subjects affected / exposed
|
26 / 6998 (0.37%) |
occurrences all number
|
26 |
Pericardial effusion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sinus arrhythmia
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Sinus bradycardia
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
8 |
Sinus tachycardia
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Supraventricular extrasystoles
|
|
subjects affected / exposed
|
10 / 6998 (0.14%) |
occurrences all number
|
10 |
Tachycardia
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Ventricular extrasystoles
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Ventricular pre-excitation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Ventricular tachycardia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nervous system disorders
|
|
Aphasia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Ataxia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Balance disorder
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Carpal tunnel syndrome
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Disturbance in attention
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Dizziness
|
|
subjects affected / exposed
|
126 / 6998 (1.80%) |
occurrences all number
|
126 |
Dizziness exertional
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dizziness postural
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dysaesthesia
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Dysgeusia
|
|
subjects affected / exposed
|
21 / 6998 (0.30%) |
occurrences all number
|
21 |
Epilepsy
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Facial spasm
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Head discomfort
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Headache
|
|
subjects affected / exposed
|
316 / 6998 (4.52%) |
occurrences all number
|
325 |
Hemiparesis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hyperaesthesia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hypertonia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hypoaesthesia
|
|
subjects affected / exposed
|
14 / 6998 (0.20%) |
occurrences all number
|
14 |
Lhermitte's sign
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Migraine
|
|
subjects affected / exposed
|
17 / 6998 (0.24%) |
occurrences all number
|
18 |
Migraine with aura
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Monoparesis
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Multiple sclerosis
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Multiple sclerosis relapse
|
|
subjects affected / exposed
|
70 / 6998 (1.00%) |
occurrences all number
|
70 |
Muscle spasticity
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Neuralgia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Neuropathy peripheral
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Optic neuritis
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Orthostatic intolerance
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Paraesthesia
|
|
subjects affected / exposed
|
29 / 6998 (0.41%) |
occurrences all number
|
29 |
Peroneal nerve palsy
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Presyncope
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Psychogenic pseudosyncope
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Radial nerve compression
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Restless legs syndrome
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Sciatica
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sensory disturbance
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Somnolence
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Syncope
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Tension headache
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Tremor
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Trigeminal neuralgia
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Visual field defect
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Blood and lymphatic system disorders
|
|
Anaemia
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Eosinopenia
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Eosinophilia
|
|
subjects affected / exposed
|
12 / 6998 (0.17%) |
occurrences all number
|
12 |
Granulocytosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Haemoglobinaemia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Leukocytosis
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Leukopenia
|
|
subjects affected / exposed
|
68 / 6998 (0.97%) |
occurrences all number
|
68 |
Lymphadenopathy
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Lymphopenia
|
|
subjects affected / exposed
|
119 / 6998 (1.70%) |
occurrences all number
|
119 |
Microcytic anaemia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Monocytopenia
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Monocytosis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Neutropenia
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Neutrophilia
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Pancytopenia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Thrombocytopenia
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Ear and labyrinth disorders
|
|
Deafness
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Ear discomfort
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Ear pain
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
External ear inflammation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sudden hearing loss
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Tinnitus
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Vertigo
|
|
subjects affected / exposed
|
68 / 6998 (0.97%) |
occurrences all number
|
69 |
Vertigo positional
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Eye disorders
|
|
Amblyopia
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Blepharospasm
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Cataract
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Diplopia
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Eye irritation
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Eye pain
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
12 |
Eye swelling
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Eyelid oedema
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Foreign body sensation in eyes
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Iridocyclitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Macular oedema
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Ocular discomfort
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Photopsia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Retinal vein thrombosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vision blurred
|
|
subjects affected / exposed
|
20 / 6998 (0.29%) |
occurrences all number
|
20 |
Visual acuity reduced
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Visual impairment
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Gastrointestinal disorders
|
|
Abdominal discomfort
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Abdominal distension
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Abdominal pain
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
10 |
Abdominal pain lower
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Abdominal pain upper
|
|
subjects affected / exposed
|
53 / 6998 (0.76%) |
occurrences all number
|
53 |
Anal incontinence
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Aphthous ulcer
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Bowel movement irregularity
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Constipation
|
|
subjects affected / exposed
|
13 / 6998 (0.19%) |
occurrences all number
|
13 |
Diarrhoea
|
|
subjects affected / exposed
|
96 / 6998 (1.37%) |
occurrences all number
|
96 |
Dry mouth
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Dyspepsia
|
|
subjects affected / exposed
|
11 / 6998 (0.16%) |
occurrences all number
|
11 |
Dysphagia
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Enteritis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Eructation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Faeces soft
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Flatulence
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Frequent bowel movements
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gastric disorder
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Gastritis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Gastrointestinal disorder
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Gastrointestinal erosion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gastrooesophageal reflux disease
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Haemorrhoids
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nausea
|
|
subjects affected / exposed
|
143 / 6998 (2.04%) |
occurrences all number
|
143 |
Odynophagia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Oral dysaesthesia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Oral pain
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Oral pruritus
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Paraesthesia oral
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Tongue blistering
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Tooth disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Toothache
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Vomiting
|
|
subjects affected / exposed
|
13 / 6998 (0.19%) |
occurrences all number
|
13 |
Skin and subcutaneous tissue disorders
|
|
Acne
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
8 |
Alopecia
|
|
subjects affected / exposed
|
15 / 6998 (0.21%) |
occurrences all number
|
15 |
Blister
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dermatitis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Dermatitis allergic
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Dermatitis contact
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Dermatitis exfoliative
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dermatosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Drug eruption
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dry skin
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dyshidrotic eczema
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Eczema
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Erythema
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Hand dermatitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hyperhidrosis
|
|
subjects affected / exposed
|
14 / 6998 (0.20%) |
occurrences all number
|
15 |
Night sweats
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Photosensitivity reaction
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pigmentation disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Pityriasis rosea
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Pruritus
|
|
subjects affected / exposed
|
24 / 6998 (0.34%) |
occurrences all number
|
24 |
Pruritus generalised
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Rash
|
|
subjects affected / exposed
|
15 / 6998 (0.21%) |
occurrences all number
|
15 |
Rash pruritic
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Rash vesicular
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Rosacea
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Seborrhoeic dermatitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Skin burning sensation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Skin disorder
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Skin exfoliation
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Skin irritation
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Skin odour abnormal
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Skin reaction
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Swelling face
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Renal and urinary disorders
|
|
Bladder dysfunction
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Dysuria
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Haematuria
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Micturition urgency
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Nephritis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Neurogenic bladder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nocturia
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Pollakiuria
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Renal pain
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Urge incontinence
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Musculoskeletal and connective tissue disorders
|
|
Arthralgia
|
|
subjects affected / exposed
|
16 / 6998 (0.23%) |
occurrences all number
|
17 |
Arthritis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Back pain
|
|
subjects affected / exposed
|
46 / 6998 (0.66%) |
occurrences all number
|
46 |
Bone pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Bursitis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Coccydynia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Flank pain
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Groin pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Intervertebral disc protrusion
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Joint stiffness
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Limb discomfort
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Mobility decreased
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Muscle fatigue
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Muscle rigidity
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Muscle spasms
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Muscle tightness
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Muscle twitching
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Muscular weakness
|
|
subjects affected / exposed
|
8 / 6998 (0.11%) |
occurrences all number
|
8 |
Musculoskeletal chest pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Musculoskeletal pain
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Musculoskeletal stiffness
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Myalgia
|
|
subjects affected / exposed
|
16 / 6998 (0.23%) |
occurrences all number
|
17 |
Myofascial pain syndrome
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Neck pain
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Pain in extremity
|
|
subjects affected / exposed
|
19 / 6998 (0.27%) |
occurrences all number
|
19 |
Spinal disorder
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Infections and infestations
|
|
Anal abscess
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Anorectal infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Bacterial infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Bronchitis
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Chronic sinusitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Conjunctivitis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Cystitis
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Dysentery
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Erysipelas
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Febrile infection
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Fungal infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gastroenteritis
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Gastroenteritis viral
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gastrointestinal infection
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Genital herpes
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Genitourinary tract infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gingivitis
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Helminthic infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Herpes simplex
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Herpes virus infection
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Herpes zoster
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Hordeolum
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Infected bite
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Infection
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Influenza
|
|
subjects affected / exposed
|
23 / 6998 (0.33%) |
occurrences all number
|
23 |
Laryngitis
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Mastoiditis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Myelitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Nasopharyngitis
|
|
subjects affected / exposed
|
137 / 6998 (1.96%) |
occurrences all number
|
137 |
Onychomycosis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Oral herpes
|
|
subjects affected / exposed
|
27 / 6998 (0.39%) |
occurrences all number
|
27 |
Pharyngitis
|
|
subjects affected / exposed
|
3 / 6998 (0.04%) |
occurrences all number
|
3 |
Pyelonephritis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Respiratory tract infection
|
|
subjects affected / exposed
|
7 / 6998 (0.10%) |
occurrences all number
|
7 |
Rhinitis
|
|
subjects affected / exposed
|
12 / 6998 (0.17%) |
occurrences all number
|
12 |
Sialoadenitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Sinusitis
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |
Tinea versicolour
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Tonsillitis
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Upper respiratory tract infection
|
|
subjects affected / exposed
|
12 / 6998 (0.17%) |
occurrences all number
|
12 |
Urinary tract infection
|
|
subjects affected / exposed
|
15 / 6998 (0.21%) |
occurrences all number
|
15 |
Vaginal abscess
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Viral infection
|
|
subjects affected / exposed
|
2 / 6998 (0.03%) |
occurrences all number
|
2 |
Viral rhinitis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vulvovaginal candidiasis
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vulvovaginal mycotic infection
|
|
subjects affected / exposed
|
5 / 6998 (0.07%) |
occurrences all number
|
5 |
Metabolism and nutrition disorders
|
|
Decreased appetite
|
|
subjects affected / exposed
|
9 / 6998 (0.13%) |
occurrences all number
|
9 |
Food craving
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Gluten sensitivity
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hyperglycaemia
|
|
subjects affected / exposed
|
4 / 6998 (0.06%) |
occurrences all number
|
4 |
Hyperkalaemia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hypoglycaemia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Hypokalaemia
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Increased appetite
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Type 2 diabetes mellitus
|
|
subjects affected / exposed
|
1 / 6998 (0.01%) |
occurrences all number
|
1 |
Vitamin D deficiency
|
|
subjects affected / exposed
|
6 / 6998 (0.09%) |
occurrences all number
|
6 |