Non-serious adverse events
|
Combination |
Monotherapy |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
278 / 304 (91.45%) |
265 / 301 (88.04%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Angiomyolipoma
|
|
|
Additional description: Angiomyolipoma
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Benign neoplasm of eyelid
|
|
|
Additional description: Benign neoplasm of eyelid
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Bowen's disease
|
|
|
Additional description: Bowen's disease
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Melanocytic naevus
|
|
|
Additional description: Melanocytic naevus
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Oral neoplasm
|
|
|
Additional description: Oral neoplasm
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Skin papilloma
|
|
|
Additional description: Skin papilloma
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
Additional description: Aortic aneurysm
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Aortic stenosis
|
|
|
Additional description: Aortic stenosis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Circulatory collapse
|
|
|
Additional description: Circulatory collapse
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Deep vein thrombosis
|
|
|
Additional description: Deep vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Flushing
|
|
|
Additional description: Flushing
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
1 / 301 (0.33%) |
occurrences all number
|
5 |
1 |
Hot flush
|
|
|
Additional description: Hot flush
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
3 / 301 (1.00%) |
occurrences all number
|
8 |
3 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
7 / 301 (2.33%) |
occurrences all number
|
4 |
7 |
Orthostatic hypotension
|
|
|
Additional description: Orthostatic hypotension
|
|
|
subjects affected / exposed
|
11 / 304 (3.62%) |
10 / 301 (3.32%) |
occurrences all number
|
15 |
12 |
Peripheral coldness
|
|
|
Additional description: Peripheral coldness
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
2 / 301 (0.66%) |
occurrences all number
|
5 |
2 |
Raynaud's phenomenon
|
|
|
Additional description: Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Varicose vein
|
|
|
Additional description: Varicose vein
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Vein disorder
|
|
|
Additional description: Vein disorder
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Surgical and medical procedures
|
|
|
Acrochordon excision
|
|
|
Additional description: Acrochordon excision
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Bartholin's cyst removal
|
|
|
Additional description: Bartholin's cyst removal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Bladder neck operation
|
|
|
Additional description: Bladder neck operation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Cataract operation
|
|
|
Additional description: Cataract operation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
3 |
Colostomy
|
|
|
Additional description: Colostomy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dental cleaning
|
|
|
Additional description: Dental cleaning
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dental implantation
|
|
|
Additional description: Dental implantation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Dental operation
|
|
|
Additional description: Dental operation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Endodontic procedure
|
|
|
Additional description: Endodontic procedure
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Eye laser surgery
|
|
|
Additional description: Eye laser surgery
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
2 |
Fasciectomy
|
|
|
Additional description: Fasciectomy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Gallbladder operation
|
|
|
Additional description: Gallbladder operation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Gingival operation
|
|
|
Additional description: Gingival operation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Hernia repair
|
|
|
Additional description: Hernia repair
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Hip arthroplasty
|
|
|
Additional description: Hip arthroplasty
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Hysterectomy
|
|
|
Additional description: Hysterectomy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Inguinal hernia repair
|
|
|
Additional description: Inguinal hernia repair
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Injection
|
|
|
Additional description: Injection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Intestinal operation
|
|
|
Additional description: Intestinal operation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Lesion excision
|
|
|
Additional description: Lesion excision
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Nasal polypectomy
|
|
|
Additional description: Nasal polypectomy
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Nasal septal operation
|
|
|
Additional description: Nasal septal operation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Removal of internal fixation
|
|
|
Additional description: Removal of internal fixation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Shoulder operation
|
|
|
Additional description: Shoulder operation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Skin lesion excision
|
|
|
Additional description: Skin lesion excision
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tooth extraction
|
|
|
Additional description: Tooth extraction
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
3 |
Tooth repair
|
|
|
Additional description: Tooth repair
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Tympanoplasty
|
|
|
Additional description: Tympanoplasty
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Wisdom teeth removal
|
|
|
Additional description: Wisdom teeth removal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
Additional description: Adverse drug reaction
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Adverse reaction
|
|
|
Additional description: Adverse reaction
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Asthenia
|
|
|
Additional description: Asthenia
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
4 / 301 (1.33%) |
occurrences all number
|
3 |
4 |
Chest discomfort
|
|
|
Additional description: Chest discomfort
|
|
|
subjects affected / exposed
|
7 / 304 (2.30%) |
12 / 301 (3.99%) |
occurrences all number
|
8 |
12 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
8 / 304 (2.63%) |
10 / 301 (3.32%) |
occurrences all number
|
12 |
12 |
Chills
|
|
|
Additional description: Chills
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
2 |
Crepitations
|
|
|
Additional description: Crepitations
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Drug resistance
|
|
|
Additional description: Drug resistance
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Facial pain
|
|
|
Additional description: Facial pain
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
45 / 304 (14.80%) |
34 / 301 (11.30%) |
occurrences all number
|
53 |
39 |
Feeling abnormal
|
|
|
Additional description: Feeling abnormal
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Feeling cold
|
|
|
Additional description: Feeling cold
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Feeling hot
|
|
|
Additional description: Feeling hot
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Influenza like illness
|
|
|
Additional description: Influenza like illness
|
|
|
subjects affected / exposed
|
13 / 304 (4.28%) |
6 / 301 (1.99%) |
occurrences all number
|
13 |
6 |
Irritability
|
|
|
Additional description: Irritability
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
6 |
Local swelling
|
|
|
Additional description: Local swelling
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Malaise
|
|
|
Additional description: Malaise
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
4 / 301 (1.33%) |
occurrences all number
|
6 |
4 |
Non-cardiac chest pain
|
|
|
Additional description: Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Oedema peripheral
|
|
|
Additional description: Oedema peripheral
|
|
|
subjects affected / exposed
|
8 / 304 (2.63%) |
7 / 301 (2.33%) |
occurrences all number
|
8 |
7 |
Pain
|
|
|
Additional description: Pain
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
4 |
1 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
6 |
Sensation of foreign body
|
|
|
Additional description: Sensation of foreign body
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Sensation of pressure
|
|
|
Additional description: Sensation of pressure
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Sluggishness
|
|
|
Additional description: Sluggishness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Swelling
|
|
|
Additional description: Swelling
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Thirst
|
|
|
Additional description: Thirst
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
3 |
0 |
Vessel puncture site haematoma
|
|
|
Additional description: Vessel puncture site haematoma
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
Additional description: Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Hypersensitivity
|
|
|
Additional description: Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
3 |
0 |
Seasonal allergy
|
|
|
Additional description: Seasonal allergy
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
4 / 301 (1.33%) |
occurrences all number
|
5 |
4 |
Social circumstances
|
|
|
Bereavement
|
|
|
Additional description: Bereavement
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Death of companion
|
|
|
Additional description: Death of companion
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Death of relative
|
|
|
Additional description: Death of relative
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Ex-tobacco user
|
|
|
Additional description: Ex-tobacco user
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Family stress
|
|
|
Additional description: Family stress
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Stress at work
|
|
|
Additional description: Stress at work
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Reproductive system and breast disorders
|
|
|
Breast tenderness
|
|
|
Additional description: Breast tenderness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
3 |
Dysmenorrhoea
|
|
|
Additional description: Dysmenorrhoea
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
2 |
Erectile dysfunction
|
|
|
Additional description: Erectile dysfunction
|
|
|
subjects affected / exposed
|
12 / 304 (3.95%) |
13 / 301 (4.32%) |
occurrences all number
|
14 |
14 |
Gynaecomastia
|
|
|
Additional description: Gynaecomastia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
3 |
Menorrhagia
|
|
|
Additional description: Menorrhagia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
3 |
Nipple disorder
|
|
|
Additional description: Nipple disorder
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Prostatic intraepithelial neoplasia
|
|
|
Additional description: Prostatic intraepithelial neoplasia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Vaginal haemorrhage
|
|
|
Additional description: Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Asthma
|
|
|
Additional description: Asthma
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
1 / 301 (0.33%) |
occurrences all number
|
4 |
1 |
Choking sensation
|
|
|
Additional description: Choking sensation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Cough
|
|
|
Additional description: Cough
|
|
|
subjects affected / exposed
|
23 / 304 (7.57%) |
24 / 301 (7.97%) |
occurrences all number
|
25 |
29 |
Dry throat
|
|
|
Additional description: Dry throat
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
2 / 301 (0.66%) |
occurrences all number
|
4 |
2 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
13 / 304 (4.28%) |
10 / 301 (3.32%) |
occurrences all number
|
13 |
11 |
Dyspnoea exertional
|
|
|
Additional description: Dyspnoea exertional
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
6 |
Epistaxis
|
|
|
Additional description: Epistaxis
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
4 / 301 (1.33%) |
occurrences all number
|
3 |
4 |
Increased upper airway secretion
|
|
|
Additional description: Increased upper airway secretion
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Nasal congestion
|
|
|
Additional description: Nasal congestion
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
7 / 301 (2.33%) |
occurrences all number
|
6 |
9 |
Nasal discomfort
|
|
|
Additional description: Nasal discomfort
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal polyps
|
|
|
Additional description: Nasal polyps
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Oropharyngeal blistering
|
|
|
Additional description: Oropharyngeal blistering
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Oropharyngeal pain
|
|
|
Additional description: Oropharyngeal pain
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
9 / 301 (2.99%) |
occurrences all number
|
6 |
10 |
Productive cough
|
|
|
Additional description: Productive cough
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
4 |
1 |
Rhinitis allergic
|
|
|
Additional description: Rhinitis allergic
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Rhinorrhoea
|
|
|
Additional description: Rhinorrhoea
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
4 / 301 (1.33%) |
occurrences all number
|
1 |
5 |
Sinus congestion
|
|
|
Additional description: Sinus congestion
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Sneezing
|
|
|
Additional description: Sneezing
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Snoring
|
|
|
Additional description: Snoring
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Throat irritation
|
|
|
Additional description: Throat irritation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Wheezing
|
|
|
Additional description: Wheezing
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
3 / 301 (1.00%) |
occurrences all number
|
2 |
3 |
Psychiatric disorders
|
|
|
Abnormal dreams
|
|
|
Additional description: Abnormal dreams
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Agitation
|
|
|
Additional description: Agitation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Anxiety
|
|
|
Additional description: Anxiety
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
6 / 301 (1.99%) |
occurrences all number
|
6 |
6 |
Bradyphrenia
|
|
|
Additional description: Bradyphrenia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
2 |
Deja vu
|
|
|
Additional description: Deja vu
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Depressed mood
|
|
|
Additional description: Depressed mood
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
3 / 301 (1.00%) |
occurrences all number
|
4 |
3 |
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
3 / 301 (1.00%) |
occurrences all number
|
2 |
3 |
Disorientation
|
|
|
Additional description: Disorientation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Dissociation
|
|
|
Additional description: Dissociation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Emotional distress
|
|
|
Additional description: Emotional distress
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Euphoric mood
|
|
|
Additional description: Euphoric mood
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Insomnia
|
|
|
Additional description: Insomnia
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
2 / 301 (0.66%) |
occurrences all number
|
7 |
2 |
Libido decreased
|
|
|
Additional description: Libido decreased
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
0 / 301 (0.00%) |
occurrences all number
|
5 |
0 |
Loss of libido
|
|
|
Additional description: Loss of libido
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Mood altered
|
|
|
Additional description: Mood altered
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Mood swings
|
|
|
Additional description: Mood swings
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Nervousness
|
|
|
Additional description: Nervousness
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Panic attack
|
|
|
Additional description: Panic attack
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
2 |
Sleep disorder
|
|
|
Additional description: Sleep disorder
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
4 / 301 (1.33%) |
occurrences all number
|
5 |
5 |
Stress
|
|
|
Additional description: Stress
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
2 |
Terminal insomnia
|
|
|
Additional description: Terminal insomnia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Arthroscopy
|
|
|
Additional description: Arthroscopy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Aspartate aminotransferase increased
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
3 |
Aspiration joint
|
|
|
Additional description: Aspiration joint
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Biopsy prostate
|
|
|
Additional description: Biopsy prostate
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Biopsy skin
|
|
|
Additional description: Biopsy skin
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood albumin abnormal
|
|
|
Additional description: Blood albumin abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood albumin increased
|
|
|
Additional description: Blood albumin increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood bicarbonate increased
|
|
|
Additional description: Blood bicarbonate increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood calcium increased
|
|
|
Additional description: Blood calcium increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Blood creatinine increased
|
|
|
Additional description: Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
2 |
Blood glucose abnormal
|
|
|
Additional description: Blood glucose abnormal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
3 |
Blood glucose increased
|
|
|
Additional description: Blood glucose increased
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
4 / 301 (1.33%) |
occurrences all number
|
7 |
6 |
Blood parathyroid hormone increased
|
|
|
Additional description: Blood parathyroid hormone increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Blood potassium abnormal
|
|
|
Additional description: Blood potassium abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Blood potassium decreased
|
|
|
Additional description: Blood potassium decreased
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
5 / 301 (1.66%) |
occurrences all number
|
5 |
6 |
Blood pressure decreased
|
|
|
Additional description: Blood pressure decreased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Blood pressure increased
|
|
|
Additional description: Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Blood sodium abnormal
|
|
|
Additional description: Blood sodium abnormal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
3 |
0 |
Blood sodium decreased
|
|
|
Additional description: Blood sodium decreased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Blood test abnormal
|
|
|
Additional description: Blood test abnormal
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
6 / 301 (1.99%) |
occurrences all number
|
3 |
7 |
Blood triglycerides increased
|
|
|
Additional description: Blood triglycerides increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Blood urea abnormal
|
|
|
Additional description: Blood urea abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood urea increased
|
|
|
Additional description: Blood urea increased
|
|
|
subjects affected / exposed
|
7 / 304 (2.30%) |
4 / 301 (1.33%) |
occurrences all number
|
15 |
6 |
Blood uric acid increased
|
|
|
Additional description: Blood uric acid increased
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
3 / 301 (1.00%) |
occurrences all number
|
7 |
4 |
Body temperature increased
|
|
|
Additional description: Body temperature increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Colonoscopy
|
|
|
Additional description: Colonoscopy
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Computerised tomogram
|
|
|
Additional description: Computerised tomogram
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Cystoscopy
|
|
|
Additional description: Cystoscopy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Exercise test
|
|
|
Additional description: Exercise test
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Free prostate-specific antigen increased
|
|
|
Additional description: Free prostate-specific antigen increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Glomerular filtration rate decreased
|
|
|
Additional description: Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Glycosylated haemoglobin increased
|
|
|
Additional description: Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Haematocrit decreased
|
|
|
Additional description: Haematocrit decreased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Haemoglobin decreased
|
|
|
Additional description: Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Heart rate increased
|
|
|
Additional description: Heart rate increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Heart rate irregular
|
|
|
Additional description: Heart rate irregular
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Intraocular pressure increased
|
|
|
Additional description: Intraocular pressure increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Liver function test abnormal
|
|
|
Additional description: Liver function test abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Lymphocyte count abnormal
|
|
|
Additional description: Lymphocyte count abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Mean cell haemoglobin concentration abnormal
|
|
|
Additional description: Mean cell haemoglobin concentration abnormal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Mean cell haemoglobin increased
|
|
|
Additional description: Mean cell haemoglobin increased
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
3 / 301 (1.00%) |
occurrences all number
|
4 |
3 |
Mean cell volume increased
|
|
|
Additional description: Mean cell volume increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Myelocyte present
|
|
|
Additional description: Myelocyte present
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Pulse pressure increased
|
|
|
Additional description: Pulse pressure increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Red blood cell count decreased
|
|
|
Additional description: Red blood cell count decreased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Red cell distribution width increased
|
|
|
Additional description: Red cell distribution width increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Sigmoidoscopy
|
|
|
Additional description: Sigmoidoscopy
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urine colour abnormal
|
|
|
Additional description: Urine colour abnormal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Urine potassium increased
|
|
|
Additional description: Urine potassium increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urine sodium increased
|
|
|
Additional description: Urine sodium increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Weight increased
|
|
|
Additional description: Weight increased
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
White blood cell count increased
|
|
|
Additional description: White blood cell count increased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Injury, poisoning and procedural complications
|
|
|
Arthropod bite
|
|
|
Additional description: Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
4 / 301 (1.33%) |
occurrences all number
|
1 |
5 |
Arthropod sting
|
|
|
Additional description: Arthropod sting
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Back injury
|
|
|
Additional description: Back injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Cartilage injury
|
|
|
Additional description: Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Contusion
|
|
|
Additional description: Contusion
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Ear injury
|
|
|
Additional description: Ear injury
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Epicondylitis
|
|
|
Additional description: Epicondylitis
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Excoriation
|
|
|
Additional description: Excoriation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Eye injury
|
|
|
Additional description: Eye injury
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Fall
|
|
|
Additional description: Fall
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
5 / 301 (1.66%) |
occurrences all number
|
6 |
6 |
Fibula fracture
|
|
|
Additional description: Fibula fracture
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Head injury
|
|
|
Additional description: Head injury
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Joint dislocation
|
|
|
Additional description: Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Joint sprain
|
|
|
Additional description: Joint sprain
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Joint injury
|
|
|
Additional description: Joint injury
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Ligament injury
|
|
|
Additional description: Ligament injury
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Limb injury
|
|
|
Additional description: Limb injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
4 / 301 (1.33%) |
occurrences all number
|
0 |
4 |
Medication error
|
|
|
Additional description: Medication error
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
3 |
0 |
Muscle injury
|
|
|
Additional description: Muscle injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Muscle rupture
|
|
|
Additional description: Muscle rupture
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle strain
|
|
|
Additional description: Muscle strain
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
4 / 301 (1.33%) |
occurrences all number
|
3 |
4 |
Neck injury
|
|
|
Additional description: Neck injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Pelvic fracture
|
|
|
Additional description: Pelvic fracture
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Procedural pain
|
|
|
Additional description: Procedural pain
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Rib fracture
|
|
|
Additional description: Rib fracture
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Skin laceration
|
|
|
Additional description: Skin laceration
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Soft tissue injury
|
|
|
Additional description: Soft tissue injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Spinal column injury
|
|
|
Additional description: Spinal column injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tendon injury
|
|
|
Additional description: Tendon injury
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tendon rupture
|
|
|
Additional description: Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Thermal burn
|
|
|
Additional description: Thermal burn
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Tooth fracture
|
|
|
Additional description: Tooth fracture
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Upper limb fracture
|
|
|
Additional description: Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Wound complication
|
|
|
Additional description: Wound complication
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Wrist fracture
|
|
|
Additional description: Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Cardiac disorders
|
|
|
Aortic valve incompetence
|
|
|
Additional description: Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Arrhythmia
|
|
|
Additional description: Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Bradycardia
|
|
|
Additional description: Bradycardia
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
3 / 301 (1.00%) |
occurrences all number
|
2 |
3 |
Cardiac flutter
|
|
|
Additional description: Cardiac flutter
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Myocardial ischaemia
|
|
|
Additional description: Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
13 / 304 (4.28%) |
13 / 301 (4.32%) |
occurrences all number
|
15 |
15 |
Tachycardia
|
|
|
Additional description: Tachycardia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
14 |
Nervous system disorders
|
|
|
Altered state of consciousness
|
|
|
Additional description: Altered state of consciousness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Amnesia
|
|
|
Additional description: Amnesia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Aphasia
|
|
|
Additional description: Aphasia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Aphonia
|
|
|
Additional description: Aphonia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Aura
|
|
|
Additional description: Aura
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Balance disorder
|
|
|
Additional description: Balance disorder
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Burning sensation
|
|
|
Additional description: Burning sensation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Cerebral haemorrhage
|
|
|
Additional description: Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Clumsiness
|
|
|
Additional description: Clumsiness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Coordination abnormal
|
|
|
Additional description: Coordination abnormal
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Crying
|
|
|
Additional description: Crying
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Disturbance in attention
|
|
|
Additional description: Disturbance in attention
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
73 / 304 (24.01%) |
62 / 301 (20.60%) |
occurrences all number
|
98 |
80 |
Dizziness exertional
|
|
|
Additional description: Dizziness exertional
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Dizziness postural
|
|
|
Additional description: Dizziness postural
|
|
|
subjects affected / exposed
|
16 / 304 (5.26%) |
12 / 301 (3.99%) |
occurrences all number
|
18 |
18 |
Drug withdrawal headache
|
|
|
Additional description: Drug withdrawal headache
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Dysaesthesia
|
|
|
Additional description: Dysaesthesia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Dysgeusia
|
|
|
Additional description: Dysgeusia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Head discomfort
|
|
|
Additional description: Head discomfort
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
51 / 304 (16.78%) |
59 / 301 (19.60%) |
occurrences all number
|
72 |
88 |
Hypoaesthesia
|
|
|
Additional description: Hypoaesthesia
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
5 / 301 (1.66%) |
occurrences all number
|
6 |
10 |
Lethargy
|
|
|
Additional description: Lethargy
|
|
|
subjects affected / exposed
|
20 / 304 (6.58%) |
22 / 301 (7.31%) |
occurrences all number
|
20 |
24 |
Memory impairment
|
|
|
Additional description: Memory impairment
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Migraine
|
|
|
Additional description: Migraine
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
7 / 301 (2.33%) |
occurrences all number
|
6 |
8 |
Migraine with aura
|
|
|
Additional description: Migraine with aura
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Nerve compression
|
|
|
Additional description: Nerve compression
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Neuralgia
|
|
|
Additional description: Neuralgia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
17 / 304 (5.59%) |
12 / 301 (3.99%) |
occurrences all number
|
19 |
13 |
Poor quality sleep
|
|
|
Additional description: Poor quality sleep
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
3 |
Presyncope
|
|
|
Additional description: Presyncope
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Restless legs syndrome
|
|
|
Additional description: Restless legs syndrome
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Sciatica
|
|
|
Additional description: Sciatica
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
5 / 301 (1.66%) |
occurrences all number
|
6 |
5 |
Sensory disturbance
|
|
|
Additional description: Sensory disturbance
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Somnolence
|
|
|
Additional description: Somnolence
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Speech disorder
|
|
|
Additional description: Speech disorder
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Syncope
|
|
|
Additional description: Syncope
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
4 / 301 (1.33%) |
occurrences all number
|
5 |
4 |
Tension headache
|
|
|
Additional description: Tension headache
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Tremor
|
|
|
Additional description: Tremor
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
VIIth nerve paralysis
|
|
|
Additional description: VIIth nerve paralysis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Ear and labyrinth disorders
|
|
|
Deafness unilateral
|
|
|
Additional description: Deafness unilateral
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Ear congestion
|
|
|
Additional description: Ear congestion
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Ear discomfort
|
|
|
Additional description: Ear discomfort
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Ear disorder
|
|
|
Additional description: Ear disorder
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Eustachian tube dysfunction
|
|
|
Additional description: Eustachian tube dysfunction
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tinnitus
|
|
|
Additional description: Tinnitus
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
4 / 301 (1.33%) |
occurrences all number
|
2 |
5 |
Tympanic membrane perforation
|
|
|
Additional description: Tympanic membrane perforation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
7 / 304 (2.30%) |
1 / 301 (0.33%) |
occurrences all number
|
7 |
6 |
Vertigo positional
|
|
|
Additional description: Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Eye disorders
|
|
|
Blepharitis
|
|
|
Additional description: Blepharitis
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
0 / 301 (0.00%) |
occurrences all number
|
4 |
0 |
Conjunctivitis
|
|
|
Additional description: Conjunctivitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Conjunctival haemorrhage
|
|
|
Additional description: Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
3 |
Conjunctivitis allergic
|
|
|
Additional description: Conjunctivitis allergic
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Dry eye
|
|
|
Additional description: Dry eye
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
2 |
Episcleritis
|
|
|
Additional description: Episcleritis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Eye disorder
|
|
|
Additional description: Eye disorder
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Eye irritation
|
|
|
Additional description: Eye irritation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Eye pain
|
|
|
Additional description: Eye pain
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Eye pruritus
|
|
|
Additional description: Eye pruritus
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Eye swelling
|
|
|
Additional description: Eye swelling
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Eyelid margin crusting
|
|
|
Additional description: Eyelid margin crusting
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Iritis
|
|
|
Additional description: Iritis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Macular degeneration
|
|
|
Additional description: Macular degeneration
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Ocular hyperaemia
|
|
|
Additional description: Ocular hyperaemia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Retinal tear
|
|
|
Additional description: Retinal tear
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Scleritis
|
|
|
Additional description: Scleritis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Vision blurred
|
|
|
Additional description: Vision blurred
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
2 |
Visual impairment
|
|
|
Additional description: Visual impairment
|
|
|
subjects affected / exposed
|
5 / 304 (1.64%) |
3 / 301 (1.00%) |
occurrences all number
|
5 |
3 |
Vitreous floaters
|
|
|
Additional description: Vitreous floaters
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
Additional description: Abdominal discomfort
|
|
|
subjects affected / exposed
|
10 / 304 (3.29%) |
9 / 301 (2.99%) |
occurrences all number
|
12 |
9 |
Abdominal distension
|
|
|
Additional description: Abdominal distension
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
5 / 301 (1.66%) |
occurrences all number
|
6 |
5 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
7 / 301 (2.33%) |
occurrences all number
|
4 |
9 |
Abdominal pain lower
|
|
|
Additional description: Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
4 / 301 (1.33%) |
occurrences all number
|
1 |
4 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
3 / 301 (1.00%) |
occurrences all number
|
4 |
3 |
Anal fissure
|
|
|
Additional description: Anal fissure
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Change of bowel habit
|
|
|
Additional description: Change of bowel habit
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Constipation
|
|
|
Additional description: Constipation
|
|
|
subjects affected / exposed
|
10 / 304 (3.29%) |
3 / 301 (1.00%) |
occurrences all number
|
10 |
3 |
Dental discomfort
|
|
|
Additional description: Dental discomfort
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
20 / 304 (6.58%) |
13 / 301 (4.32%) |
occurrences all number
|
21 |
13 |
Diverticulum
|
|
|
Additional description: Diverticulum
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Dry mouth
|
|
|
Additional description: Dry mouth
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
5 / 301 (1.66%) |
occurrences all number
|
4 |
5 |
Dyspepsia
|
|
|
Additional description: Dyspepsia
|
|
|
subjects affected / exposed
|
16 / 304 (5.26%) |
3 / 301 (1.00%) |
occurrences all number
|
18 |
3 |
Dysphagia
|
|
|
Additional description: Dysphagia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Faeces discoloured
|
|
|
Additional description: Faeces discoloured
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Flatulence
|
|
|
Additional description: Flatulence
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
0 / 301 (0.00%) |
occurrences all number
|
3 |
0 |
Food poisoning
|
|
|
Additional description: Food poisoning
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Frequent bowel movements
|
|
|
Additional description: Frequent bowel movements
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Gastrointestinal haemorrhage
|
|
|
Additional description: Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal motility disorder
|
|
|
Additional description: Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
3 |
Gingival pain
|
|
|
Additional description: Gingival pain
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Gingival recession
|
|
|
Additional description: Gingival recession
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Haematochezia
|
|
|
Additional description: Haematochezia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Haemorrhoids
|
|
|
Additional description: Haemorrhoids
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Hiatus hernia
|
|
|
Additional description: Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Irritable bowel syndrome
|
|
|
Additional description: Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Lip dry
|
|
|
Additional description: Lip dry
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Lip swelling
|
|
|
Additional description: Lip swelling
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
20 / 304 (6.58%) |
14 / 301 (4.65%) |
occurrences all number
|
26 |
16 |
Oral pain
|
|
|
Additional description: Oral pain
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Proctalgia
|
|
|
Additional description: Proctalgia
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Rectal haemorrhage
|
|
|
Additional description: Rectal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
3 / 301 (1.00%) |
occurrences all number
|
7 |
3 |
Tongue coated
|
|
|
Additional description: Tongue coated
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tongue geographic
|
|
|
Additional description: Tongue geographic
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Tongue ulceration
|
|
|
Additional description: Tongue ulceration
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tooth loss
|
|
|
Additional description: Tooth loss
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Toothache
|
|
|
Additional description: Toothache
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
2 |
Vomiting
|
|
|
Additional description: Vomiting
|
|
|
subjects affected / exposed
|
14 / 304 (4.61%) |
9 / 301 (2.99%) |
occurrences all number
|
14 |
10 |
Hepatobiliary disorders
|
|
|
Biliary dilatation
|
|
|
Additional description: Biliary dilatation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Cholelithiasis
|
|
|
Additional description: Cholelithiasis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Hepatic steatosis
|
|
|
Additional description: Hepatic steatosis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
Additional description: Actinic keratosis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Alopecia
|
|
|
Additional description: Alopecia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
3 |
Blood blister
|
|
|
Additional description: Blood blister
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Dandruff
|
|
|
Additional description: Dandruff
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dermal cyst
|
|
|
Additional description: Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dermatitis
|
|
|
Additional description: Dermatitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Dry skin
|
|
|
Additional description: Dry skin
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Eczema
|
|
|
Additional description: Eczema
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Hair texture abnormal
|
|
|
Additional description: Hair texture abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Heat rash
|
|
|
Additional description: Heat rash
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Hyperhidrosis
|
|
|
Additional description: Hyperhidrosis
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
7 / 301 (2.33%) |
occurrences all number
|
5 |
7 |
Increased tendency to bruise
|
|
|
Additional description: Increased tendency to bruise
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Intertrigo
|
|
|
Additional description: Intertrigo
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Night sweats
|
|
|
Additional description: Night sweats
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Pain of skin
|
|
|
Additional description: Pain of skin
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Papule
|
|
|
Additional description: Papule
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Pemphigus
|
|
|
Additional description: Pemphigus
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Petechiae
|
|
|
Additional description: Petechiae
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Pruritus
|
|
|
Additional description: Pruritus
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
11 / 301 (3.65%) |
occurrences all number
|
6 |
11 |
Pruritus generalised
|
|
|
Additional description: Pruritus generalised
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Psoriasis
|
|
|
Additional description: Psoriasis
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Rash
|
|
|
Additional description: Rash
|
|
|
subjects affected / exposed
|
12 / 304 (3.95%) |
16 / 301 (5.32%) |
occurrences all number
|
12 |
22 |
Rash erythematous
|
|
|
Additional description: Rash erythematous
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Rash generalised
|
|
|
Additional description: Rash generalised
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Rash macular
|
|
|
Additional description: Rash macular
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Rash papular
|
|
|
Additional description: Rash papular
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Rash pruritic
|
|
|
Additional description: Rash pruritic
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Rosacea
|
|
|
Additional description: Rosacea
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Skin burning sensation
|
|
|
Additional description: Skin burning sensation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Skin discolouration
|
|
|
Additional description: Skin discolouration
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
5 |
Skin disorder
|
|
|
Additional description: Skin disorder
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Skin irritation
|
|
|
Additional description: Skin irritation
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
2 |
Skin lesion
|
|
|
Additional description: Skin lesion
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Skin plaque
|
|
|
Additional description: Skin plaque
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Skin sensitisation
|
|
|
Additional description: Skin sensitisation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Stasis dermatitis
|
|
|
Additional description: Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Swelling face
|
|
|
Additional description: Swelling face
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Urticaria
|
|
|
Additional description: Urticaria
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Renal and urinary disorders
|
|
|
Bladder discomfort
|
|
|
Additional description: Bladder discomfort
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dysuria
|
|
|
Additional description: Dysuria
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
3 / 301 (1.00%) |
occurrences all number
|
1 |
4 |
Glycosuria
|
|
|
Additional description: Glycosuria
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Haematuria
|
|
|
Additional description: Haematuria
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Micturition urgency
|
|
|
Additional description: Micturition urgency
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Nephrolithiasis
|
|
|
Additional description: Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Nocturia
|
|
|
Additional description: Nocturia
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
1 / 301 (0.33%) |
occurrences all number
|
6 |
1 |
Oliguria
|
|
|
Additional description: Oliguria
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Pollakiuria
|
|
|
Additional description: Pollakiuria
|
|
|
subjects affected / exposed
|
10 / 304 (3.29%) |
12 / 301 (3.99%) |
occurrences all number
|
11 |
12 |
Polyuria
|
|
|
Additional description: Polyuria
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Proteinuria
|
|
|
Additional description: Proteinuria
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Urge incontinence
|
|
|
Additional description: Urge incontinence
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urinary hesitation
|
|
|
Additional description: Urinary hesitation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urinary tract disorder
|
|
|
Additional description: Urinary tract disorder
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urine abnormality
|
|
|
Additional description: Urine abnormality
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urine flow decreased
|
|
|
Additional description: Urine flow decreased
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Urine odour abnormal
|
|
|
Additional description: Urine odour abnormal
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Endocrine disorders
|
|
|
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
Ankylosing spondylitis
|
|
|
Additional description: Ankylosing spondylitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
17 / 304 (5.59%) |
19 / 301 (6.31%) |
occurrences all number
|
17 |
27 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
0 / 301 (0.00%) |
occurrences all number
|
4 |
0 |
Arthropathy
|
|
|
Additional description: Arthropathy
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Back disorder
|
|
|
Additional description: Back disorder
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
14 / 304 (4.61%) |
21 / 301 (6.98%) |
occurrences all number
|
15 |
23 |
Bunion
|
|
|
Additional description: Bunion
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Costochondritis
|
|
|
Additional description: Costochondritis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Dupuytren's contracture
|
|
|
Additional description: Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Fibromyalgia
|
|
|
Additional description: Fibromyalgia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
2 |
Flank pain
|
|
|
Additional description: Flank pain
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
2 |
3 |
Groin pain
|
|
|
Additional description: Groin pain
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Joint crepitation
|
|
|
Additional description: Joint crepitation
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Joint stiffness
|
|
|
Additional description: Joint stiffness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Joint swelling
|
|
|
Additional description: Joint swelling
|
|
|
subjects affected / exposed
|
14 / 304 (4.61%) |
11 / 301 (3.65%) |
occurrences all number
|
15 |
16 |
Limb discomfort
|
|
|
Additional description: Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Lumbar spinal stenosis
|
|
|
Additional description: Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Muscle fatigue
|
|
|
Additional description: Muscle fatigue
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle spasms
|
|
|
Additional description: Muscle spasms
|
|
|
subjects affected / exposed
|
15 / 304 (4.93%) |
11 / 301 (3.65%) |
occurrences all number
|
18 |
15 |
Muscle tightness
|
|
|
Additional description: Muscle tightness
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Muscular weakness
|
|
|
Additional description: Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Musculoskeletal chest pain
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
4 / 301 (1.33%) |
occurrences all number
|
1 |
4 |
Musculoskeletal pain
|
|
|
Additional description: Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
14 / 301 (4.65%) |
occurrences all number
|
3 |
17 |
Musculoskeletal stiffness
|
|
|
Additional description: Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
1 / 301 (0.33%) |
occurrences all number
|
3 |
1 |
Myalgia
|
|
|
Additional description: Myalgia
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
5 / 301 (1.66%) |
occurrences all number
|
3 |
5 |
Neck pain
|
|
|
Additional description: Neck pain
|
|
|
subjects affected / exposed
|
6 / 304 (1.97%) |
6 / 301 (1.99%) |
occurrences all number
|
6 |
6 |
Osteoarthritis
|
|
|
Additional description: Osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Osteoporosis
|
|
|
Additional description: Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Pain in jaw
|
|
|
Additional description: Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
21 / 304 (6.91%) |
14 / 301 (4.65%) |
occurrences all number
|
25 |
16 |
Periarthritis
|
|
|
Additional description: Periarthritis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Pubic pain
|
|
|
Additional description: Pubic pain
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Rotator cuff syndrome
|
|
|
Additional description: Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Sensation of heaviness
|
|
|
Additional description: Sensation of heaviness
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
3 / 301 (1.00%) |
occurrences all number
|
0 |
3 |
Spinal osteoarthritis
|
|
|
Additional description: Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Synovial cyst
|
|
|
Additional description: Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Trigger finger
|
|
|
Additional description: Trigger finger
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Infections and infestations
|
|
|
Acute sinusitis
|
|
|
Additional description: Acute sinusitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Alveolar osteitis
|
|
|
Additional description: Alveolar osteitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial infection
|
|
|
Additional description: Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Bronchitis
|
|
|
Additional description: Bronchitis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Candidiasis
|
|
|
Additional description: Candidiasis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Cellulitis
|
|
|
Additional description: Cellulitis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Dermatitis infected
|
|
|
Additional description: Dermatitis infected
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Diverticulitis
|
|
|
Additional description: Diverticulitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Ear infection
|
|
|
Additional description: Ear infection
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
3 / 301 (1.00%) |
occurrences all number
|
2 |
4 |
Eye infection
|
|
|
Additional description: Eye infection
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Fungal infection
|
|
|
Additional description: Fungal infection
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Furuncle
|
|
|
Additional description: Furuncle
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Gastroenteritis viral
|
|
|
Additional description: Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
2 |
Gastrointestinal viral infection
|
|
|
Additional description: Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Gingival abscess
|
|
|
Additional description: Gingival abscess
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Gingival infection
|
|
|
Additional description: Gingival infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
4 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
10 / 304 (3.29%) |
9 / 301 (2.99%) |
occurrences all number
|
10 |
9 |
Infected bites
|
|
|
Additional description: Infected bites
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Labyrinthitis
|
|
|
Additional description: Labyrinthitis
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
1 / 301 (0.33%) |
occurrences all number
|
4 |
1 |
Laryngitis
|
|
|
Additional description: Laryngitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
4 / 301 (1.33%) |
occurrences all number
|
1 |
4 |
Localised infection
|
|
|
Additional description: Localised infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Lower respiratory tract infection
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
9 / 304 (2.96%) |
11 / 301 (3.65%) |
occurrences all number
|
10 |
12 |
Lyme disease
|
|
|
Additional description: Lyme disease
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Mastoiditis
|
|
|
Additional description: Mastoiditis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Myringitis
|
|
|
Additional description: Myringitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Nail infection
|
|
|
Additional description: Nail infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Nasopharyngitis
|
|
|
Additional description: Nasopharyngitis
|
|
|
subjects affected / exposed
|
48 / 304 (15.79%) |
39 / 301 (12.96%) |
occurrences all number
|
61 |
51 |
Oral candidiasis
|
|
|
Additional description: Oral candidiasis
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Oral infection
|
|
|
Additional description: Oral infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Otitis externa
|
|
|
Additional description: Otitis externa
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Otitis media
|
|
|
Additional description: Otitis media
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Pharyngitis
|
|
|
Additional description: Pharyngitis
|
|
|
subjects affected / exposed
|
4 / 304 (1.32%) |
4 / 301 (1.33%) |
occurrences all number
|
4 |
5 |
Pilonidal cyst
|
|
|
Additional description: Pilonidal cyst
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Prostate infection
|
|
|
Additional description: Prostate infection
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Respiratory tract infection
|
|
|
Additional description: Respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Rhinitis
|
|
|
Additional description: Rhinitis
|
|
|
subjects affected / exposed
|
8 / 304 (2.63%) |
8 / 301 (2.66%) |
occurrences all number
|
8 |
10 |
Sialoadenitis
|
|
|
Additional description: Sialoadenitis
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
5 / 301 (1.66%) |
occurrences all number
|
3 |
5 |
Skin infection
|
|
|
Additional description: Skin infection
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Subcutaneous abscess
|
|
|
Additional description: Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Tinea pedis
|
|
|
Additional description: Tinea pedis
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Tooth abscess
|
|
|
Additional description: Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Tooth infection
|
|
|
Additional description: Tooth infection
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
3 / 301 (1.00%) |
occurrences all number
|
4 |
3 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
13 / 304 (4.28%) |
13 / 301 (4.32%) |
occurrences all number
|
17 |
21 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
8 / 304 (2.63%) |
7 / 301 (2.33%) |
occurrences all number
|
13 |
8 |
Viral infection
|
|
|
Additional description: Viral infection
|
|
|
subjects affected / exposed
|
11 / 304 (3.62%) |
4 / 301 (1.33%) |
occurrences all number
|
12 |
4 |
Viral pharyngitis
|
|
|
Additional description: Viral pharyngitis
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Viral upper respiratory tract infection
|
|
|
Additional description: Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
2 / 301 (0.66%) |
occurrences all number
|
0 |
2 |
Vulvovaginal candidiasis
|
|
|
Additional description: Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
Additional description: Decreased appetite
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
2 |
Dehydration
|
|
|
Additional description: Dehydration
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Diabetes mellitus inadequate control
|
|
|
Additional description: Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |
Fluid retention
|
|
|
Additional description: Fluid retention
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Glucose tolerance impaired
|
|
|
Additional description: Glucose tolerance impaired
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
1 / 301 (0.33%) |
occurrences all number
|
0 |
1 |
Gout
|
|
|
Additional description: Gout
|
|
|
subjects affected / exposed
|
3 / 304 (0.99%) |
2 / 301 (0.66%) |
occurrences all number
|
3 |
3 |
Hypercalcaemia
|
|
|
Additional description: Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercholesterolaemia
|
|
|
Additional description: Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Hyperglycaemia
|
|
|
Additional description: Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Hypocalcaemia
|
|
|
Additional description: Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
1 / 301 (0.33%) |
occurrences all number
|
1 |
1 |
Hypokalaemic syndrome
|
|
|
Additional description: Hypokalaemic syndrome
|
|
|
subjects affected / exposed
|
0 / 304 (0.00%) |
4 / 301 (1.33%) |
occurrences all number
|
0 |
4 |
Hyponatraemia
|
|
|
Additional description: Hyponatraemia
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
0 / 301 (0.00%) |
occurrences all number
|
2 |
0 |
Hyponatraemic syndrome
|
|
|
Additional description: Hyponatraemic syndrome
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolic syndrome
|
|
|
Additional description: Metabolic syndrome
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
0 / 301 (0.00%) |
occurrences all number
|
1 |
0 |
Type 2 diabetes mellitus
|
|
|
Additional description: Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 304 (0.66%) |
1 / 301 (0.33%) |
occurrences all number
|
2 |
1 |
Vitamin D deficiency
|
|
|
Additional description: Vitamin D deficiency
|
|
|
subjects affected / exposed
|
1 / 304 (0.33%) |
2 / 301 (0.66%) |
occurrences all number
|
1 |
2 |