Non-serious adverse events
|
Placebo |
Ibrutinib |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
164 / 168 (97.62%) |
164 / 170 (96.47%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adenoma benign
|
|
|
Additional description: Adenoma benign
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Angiolipoma
|
|
|
Additional description: Angiolipoma
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Bowen's disease
|
|
|
Additional description: Bowen's disease
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Cancer fatigue
|
|
|
Additional description: Cancer fatigue
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Colon adenoma
|
|
|
Additional description: Colon adenoma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Fibroma
|
|
|
Additional description: Fibroma
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Haemangioma of liver
|
|
|
Additional description: Haemangioma of liver
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Kidney angiomyolipoma
|
|
|
Additional description: Kidney angiomyolipoma
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Lipoma
|
|
|
Additional description: Lipoma
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Melanocytic naevus
|
|
|
Additional description: Melanocytic naevus
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
2 |
Seborrhoeic keratosis
|
|
|
Additional description: Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Skin papilloma
|
|
|
Additional description: Skin papilloma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Sweat gland tumour
|
|
|
Additional description: Sweat gland tumour
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Vascular disorders
|
|
|
Aortic aneurysm
|
|
|
Additional description: Aortic aneurysm
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Arteriosclerosis
|
|
|
Additional description: Arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Circulatory collapse
|
|
|
Additional description: Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Flushing
|
|
|
Additional description: Flushing
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
3 |
Haematoma
|
|
|
Additional description: Haematoma
|
|
|
subjects affected / exposed
|
9 / 168 (5.36%) |
28 / 170 (16.47%) |
occurrences all number
|
11 |
40 |
Hot flush
|
|
|
Additional description: Hot flush
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
2 / 170 (1.18%) |
occurrences all number
|
4 |
2 |
Hypertension
|
|
|
Additional description: Hypertension
|
|
|
subjects affected / exposed
|
12 / 168 (7.14%) |
28 / 170 (16.47%) |
occurrences all number
|
12 |
31 |
Hypertensive crisis
|
|
|
Additional description: Hypertensive crisis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
3 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Additional description: Musculoskeletal and connective tissue disorders
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Orthostatic hypotension
|
|
|
Additional description: Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral vascular disorder
|
|
|
Additional description: Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Thrombophlebitis
|
|
|
Additional description: Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Thrombosis
|
|
|
Additional description: Thrombosis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Varicophlebitis
|
|
|
Additional description: Varicophlebitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Varicose vein
|
|
|
Additional description: Varicose vein
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Surgical and medical procedures
|
|
|
Bunion operation
|
|
|
Additional description: Bunion operation
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Carpal tunnel decompression
|
|
|
Additional description: Carpal tunnel decompression
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Dental implantation
|
|
|
Additional description: Dental implantation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dental operation
|
|
|
Additional description: Dental operation
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Dental prosthesis placement
|
|
|
Additional description: Dental prosthesis placement
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Foot operation
|
|
|
Additional description: Foot operation
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hernia repair
|
|
|
Additional description: Hernia repair
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Jaw operation
|
|
|
Additional description: Jaw operation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Inguinal hernia repair
|
|
|
Additional description: Inguinal hernia repair
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Lipoma excision
|
|
|
Additional description: Lipoma excision
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Renal stone removal
|
|
|
Additional description: Renal stone removal
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Tooth extraction
|
|
|
Additional description: Tooth extraction
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
Additional description: Asthenia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Axillary pain
|
|
|
Additional description: Axillary pain
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
4 / 170 (2.35%) |
occurrences all number
|
8 |
4 |
Chills
|
|
|
Additional description: Chills
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Discomfort
|
|
|
Additional description: Discomfort
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
35 / 168 (20.83%) |
47 / 170 (27.65%) |
occurrences all number
|
39 |
61 |
Extravasation
|
|
|
Additional description: Extravasation
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Gait disturbance
|
|
|
Additional description: Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
General physical health deterioration
|
|
|
Additional description: General physical health deterioration
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
0 / 170 (0.00%) |
occurrences all number
|
5 |
0 |
General symptom
|
|
|
Additional description: General symptom
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Ill-defined disorder
|
|
|
Additional description: Ill-defined disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Impaired healing
|
|
|
Additional description: Impaired healing
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Inflammation
|
|
|
Additional description: Inflammation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
4 |
Influenza like illness
|
|
|
Additional description: Influenza like illness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
4 |
Mucosal inflammation
|
|
|
Additional description: Mucosal inflammation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Malaise
|
|
|
Additional description: Malaise
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
5 / 170 (2.94%) |
occurrences all number
|
2 |
5 |
Oedema
|
|
|
Additional description: Oedema
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
1 |
4 |
Oedema peripheral
|
|
|
Additional description: Oedema peripheral
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
12 / 170 (7.06%) |
occurrences all number
|
3 |
14 |
Performance status decreased
|
|
|
Additional description: Performance status decreased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Pain
|
|
|
Additional description: Pain
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
2 |
6 |
Peripheral swelling
|
|
|
Additional description: Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
5 / 170 (2.94%) |
occurrences all number
|
0 |
6 |
Polyp
|
|
|
Additional description: Polyp
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
7 / 170 (4.12%) |
occurrences all number
|
3 |
8 |
Sensation of foreign body
|
|
|
Additional description: Sensation of foreign body
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Swelling
|
|
|
Additional description: Swelling
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Swelling face
|
|
|
Additional description: Swelling face
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Temperature intolerance
|
|
|
Additional description: Temperature intolerance
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Ulcer
|
|
|
Additional description: Ulcer
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Vaccination site reaction
|
|
|
Additional description: Vaccination site reaction
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Immune system disorders
|
|
|
Allergy to arthropod bite
|
|
|
Additional description: Allergy to arthropod bite
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Autoimmune disorder
|
|
|
Additional description: Autoimmune disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hypersensitivity
|
|
|
Additional description: Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Immunisation reaction
|
|
|
Additional description: Immunisation reaction
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Seasonal allergy
|
|
|
Additional description: Seasonal allergy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
4 |
Reproductive system and breast disorders
|
|
|
Balanoposthitis
|
|
|
Additional description: Balanoposthitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Benign prostatic hyperplasia
|
|
|
Additional description: Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
6 / 170 (3.53%) |
occurrences all number
|
1 |
6 |
Breast cyst
|
|
|
Additional description: Breast cyst
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Breast pain
|
|
|
Additional description: Breast pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Endometrial hyperplasia
|
|
|
Additional description: Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Erectile dysfunction
|
|
|
Additional description: Erectile dysfunction
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
3 |
Genital pain
|
|
|
Additional description: Genital pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gynaecomastia
|
|
|
Additional description: Gynaecomastia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Menopausal symptoms
|
|
|
Additional description: Menopausal symptoms
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Metrorrhagia
|
|
|
Additional description: Metrorrhagia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Orchitis noninfective
|
|
|
Additional description: Orchitis noninfective
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Postmenopausal haemorrhage
|
|
|
Additional description: Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Rectocele
|
|
|
Additional description: Rectocele
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Prostatitis
|
|
|
Additional description: Prostatitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Scrotal pain
|
|
|
Additional description: Scrotal pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Testicular pain
|
|
|
Additional description: Testicular pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Vulvovaginal pain
|
|
|
Additional description: Vulvovaginal pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Uterine polyp
|
|
|
Additional description: Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Allergic cough
|
|
|
Additional description: Allergic cough
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Asthma
|
|
|
Additional description: Asthma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Bronchitis chronic
|
|
|
Additional description: Bronchitis chronic
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Bronchostenosis
|
|
|
Additional description: Bronchostenosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Chronic obstructive pulmonary disease
|
|
|
Additional description: Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Cough
|
|
|
Additional description: Cough
|
|
|
subjects affected / exposed
|
13 / 168 (7.74%) |
14 / 170 (8.24%) |
occurrences all number
|
17 |
18 |
Emphysema
|
|
|
Additional description: Emphysema
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Dysphonia
|
|
|
Additional description: Dysphonia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
9 / 168 (5.36%) |
10 / 170 (5.88%) |
occurrences all number
|
10 |
11 |
Dyspnoea exertional
|
|
|
Additional description: Dyspnoea exertional
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
4 / 170 (2.35%) |
occurrences all number
|
7 |
5 |
Epistaxis
|
|
|
Additional description: Epistaxis
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
21 / 170 (12.35%) |
occurrences all number
|
4 |
29 |
Haemoptysis
|
|
|
Additional description: Haemoptysis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Increased bronchial secretion
|
|
|
Additional description: Increased bronchial secretion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Laryngeal haemorrhage
|
|
|
Additional description: Laryngeal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Lung hypoinflation
|
|
|
Additional description: Lung hypoinflation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Nasal septum deviation
|
|
|
Additional description: Nasal septum deviation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oropharyngeal discomfort
|
|
|
Additional description: Oropharyngeal discomfort
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oropharyngeal pain
|
|
|
Additional description: Oropharyngeal pain
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
5 / 170 (2.94%) |
occurrences all number
|
9 |
7 |
Pharyngeal oedema
|
|
|
Additional description: Pharyngeal oedema
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pleural effusion
|
|
|
Additional description: Pleural effusion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Pulmonary pain
|
|
|
Additional description: Pulmonary pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Rhinitis allergic
|
|
|
Additional description: Rhinitis allergic
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
3 |
2 |
Rhinorrhoea
|
|
|
Additional description: Rhinorrhoea
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
1 |
4 |
Sleep apnoea syndrome
|
|
|
Additional description: Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Throat clearing
|
|
|
Additional description: Throat clearing
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Tonsillar hypertrophy
|
|
|
Additional description: Tonsillar hypertrophy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Psychiatric disorders
|
|
|
Agitation
|
|
|
Additional description: Agitation
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Aggression
|
|
|
Additional description: Aggression
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Anxiety disorder
|
|
|
Additional description: Anxiety disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Anxiety
|
|
|
Additional description: Anxiety
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Aversion
|
|
|
Additional description: Aversion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Depressed mood
|
|
|
Additional description: Depressed mood
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Confusional state
|
|
|
Additional description: Confusional state
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
3 / 170 (1.76%) |
occurrences all number
|
4 |
3 |
Initial insomnia
|
|
|
Additional description: Initial insomnia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Insomnia
|
|
|
Additional description: Insomnia
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
5 / 170 (2.94%) |
occurrences all number
|
6 |
5 |
Libido decreased
|
|
|
Additional description: Libido decreased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Listless
|
|
|
Additional description: Listless
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Mood altered
|
|
|
Additional description: Mood altered
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Nervousness
|
|
|
Additional description: Nervousness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Panic attack
|
|
|
Additional description: Panic attack
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Psychotic disorder
|
|
|
Additional description: Psychotic disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Restlessness
|
|
|
Additional description: Restlessness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Sleep disorder
|
|
|
Additional description: Sleep disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
10 / 170 (5.88%) |
occurrences all number
|
1 |
12 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
6 |
Arthroscopy
|
|
|
Additional description: Arthroscopy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Aspartate aminotransferase increased
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
4 |
Biopsy prostate
|
|
|
Additional description: Biopsy prostate
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Blood alkaline phosphatase increased
|
|
|
Additional description: Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
0 / 170 (0.00%) |
occurrences all number
|
3 |
0 |
Blood bilirubin increased
|
|
|
Additional description: Blood bilirubin increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
6 |
Blood cholesterol increased
|
|
|
Additional description: Blood cholesterol increased
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Blood creatine phosphokinase increased
|
|
|
Additional description: Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blood creatinine increased
|
|
|
Additional description: Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Blood glucose increased
|
|
|
Additional description: Blood glucose increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blood immunoglobulin G decreased
|
|
|
Additional description: Blood immunoglobulin G decreased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Blood lactate dehydrogenase increased
|
|
|
Additional description: Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blood potassium decreased
|
|
|
Additional description: Blood potassium decreased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Blood thyroid stimulating hormone increased
|
|
|
Additional description: Blood thyroid stimulating hormone increased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Blood uric acid increased
|
|
|
Additional description: Blood uric acid increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Cardiac murmur
|
|
|
Additional description: Cardiac murmur
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Blood urea increased
|
|
|
Additional description: Blood urea increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Electrocardiogram repolarisation abnormality
|
|
|
Additional description: Electrocardiogram repolarisation abnormality
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Electrocardiogram ST segment depression
|
|
|
Additional description: Electrocardiogram ST segment depression
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
Additional description: Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
3 / 170 (1.76%) |
occurrences all number
|
3 |
4 |
Hepatic enzyme increased
|
|
|
Additional description: Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Heart rate irregular
|
|
|
Additional description: Heart rate irregular
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Immunoglobulins decreased
|
|
|
Additional description: Immunoglobulins decreased
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Lipase increased
|
|
|
Additional description: Lipase increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Prostatic specific antigen increased
|
|
|
Additional description: Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Smear cervix
|
|
|
Additional description: Smear cervix
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Transaminases increased
|
|
|
Additional description: Transaminases increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
4 |
Urine uric acid increased
|
|
|
Additional description: Urine uric acid increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Weight increased
|
|
|
Additional description: Weight increased
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Weight decreased
|
|
|
Additional description: Weight decreased
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
4 / 170 (2.35%) |
occurrences all number
|
4 |
4 |
Injury, poisoning and procedural complications
|
|
|
Acetabulum fracture
|
|
|
Additional description: Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Accident at work
|
|
|
Additional description: Accident at work
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Animal scratch
|
|
|
Additional description: Animal scratch
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Ankle fracture
|
|
|
Additional description: Ankle fracture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Arthropod bite
|
|
|
Additional description: Arthropod bite
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
4 / 170 (2.35%) |
occurrences all number
|
2 |
7 |
Arthropod sting
|
|
|
Additional description: Arthropod sting
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bone contusion
|
|
|
Additional description: Bone contusion
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Burn oral cavity
|
|
|
Additional description: Burn oral cavity
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cartilage injury
|
|
|
Additional description: Cartilage injury
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Concussion
|
|
|
Additional description: Concussion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Contusion
|
|
|
Additional description: Contusion
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
8 / 170 (4.71%) |
occurrences all number
|
2 |
10 |
Fall
|
|
|
Additional description: Fall
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Foot fracture
|
|
|
Additional description: Foot fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Fracture
|
|
|
Additional description: Fracture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hand fracture
|
|
|
Additional description: Hand fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Ilium fracture
|
|
|
Additional description: Ilium fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Joint injury
|
|
|
Additional description: Joint injury
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Infusion related reaction
|
|
|
Additional description: Infusion related reaction
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Injury corneal
|
|
|
Additional description: Injury corneal
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Laceration
|
|
|
Additional description: Laceration
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Ligament rupture
|
|
|
Additional description: Ligament rupture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
4 / 170 (2.35%) |
occurrences all number
|
0 |
4 |
Ligament sprain
|
|
|
Additional description: Ligament sprain
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Limb injury
|
|
|
Additional description: Limb injury
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Lumbar vertebral fracture
|
|
|
Additional description: Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle rupture
|
|
|
Additional description: Muscle rupture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Meniscus injury
|
|
|
Additional description: Meniscus injury
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Muscle strain
|
|
|
Additional description: Muscle strain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Nail avulsion
|
|
|
Additional description: Nail avulsion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Patella fracture
|
|
|
Additional description: Patella fracture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Post-traumatic pain
|
|
|
Additional description: Post-traumatic pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin laceration
|
|
|
Additional description: Skin laceration
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Spinal compression fracture
|
|
|
Additional description: Spinal compression fracture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Spinal fracture
|
|
|
Additional description: Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin abrasion
|
|
|
Additional description: Skin abrasion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Sunburn
|
|
|
Additional description: Sunburn
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Traumatic fracture
|
|
|
Additional description: Traumatic fracture
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Traumatic haematoma
|
|
|
Additional description: Traumatic haematoma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Wound complication
|
|
|
Additional description: Wound complication
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Wound
|
|
|
Additional description: Wound
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Congenital, familial and genetic disorders
|
|
|
Atrial septal defect
|
|
|
Additional description: Atrial septal defect
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Factor V Leiden mutation
|
|
|
Additional description: Factor V Leiden mutation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hereditary motor and sensory neuropathy
|
|
|
Additional description: Hereditary motor and sensory neuropathy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hydrocele
|
|
|
Additional description: Hydrocele
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Phimosis
|
|
|
Additional description: Phimosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
Additional description: Acute myocardial infarction
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Angina pectoris
|
|
|
Additional description: Angina pectoris
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Aortic valve incompetence
|
|
|
Additional description: Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Arrhythmia
|
|
|
Additional description: Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Arteriosclerosis coronary artery
|
|
|
Additional description: Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
16 / 170 (9.41%) |
occurrences all number
|
9 |
16 |
Atrioventricular block first degree
|
|
|
Additional description: Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiovascular disorder
|
|
|
Additional description: Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
6 |
Bradycardia
|
|
|
Additional description: Bradycardia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Cardiac failure
|
|
|
Additional description: Cardiac failure
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiomegaly
|
|
|
Additional description: Cardiomegaly
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Coronary artery disease
|
|
|
Additional description: Coronary artery disease
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Coronary artery stenosis
|
|
|
Additional description: Coronary artery stenosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Hypertensive heart disease
|
|
|
Additional description: Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Left ventricular hypertrophy
|
|
|
Additional description: Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Mitral valve incompetence
|
|
|
Additional description: Mitral valve incompetence
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
3 / 170 (1.76%) |
occurrences all number
|
6 |
4 |
Pericardial effusion
|
|
|
Additional description: Pericardial effusion
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Sinus tachycardia
|
|
|
Additional description: Sinus tachycardia
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Sinus bradycardia
|
|
|
Additional description: Sinus bradycardia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tachyarrhythmia
|
|
|
Additional description: Tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tachycardia
|
|
|
Additional description: Tachycardia
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
5 / 170 (2.94%) |
occurrences all number
|
4 |
5 |
Tricuspid valve incompetence
|
|
|
Additional description: Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Ventricular extrasystoles
|
|
|
Additional description: Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Nervous system disorders
|
|
|
Ageusia
|
|
|
Additional description: Ageusia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Balance disorder
|
|
|
Additional description: Balance disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Basilar migraine
|
|
|
Additional description: Basilar migraine
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cognitive disorder
|
|
|
Additional description: Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Carotid artery stenosis
|
|
|
Additional description: Carotid artery stenosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Carpal tunnel syndrome
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Cervical syndrome
|
|
|
Additional description: Cervical syndrome
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cervicobrachial syndrome
|
|
|
Additional description: Cervicobrachial syndrome
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Convulsion
|
|
|
Additional description: Convulsion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dementia
|
|
|
Additional description: Dementia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
11 / 168 (6.55%) |
26 / 170 (15.29%) |
occurrences all number
|
13 |
41 |
Diabetic neuropathy
|
|
|
Additional description: Diabetic neuropathy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Disturbance in attention
|
|
|
Additional description: Disturbance in attention
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Dysaesthesia
|
|
|
Additional description: Dysaesthesia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Dysgeusia
|
|
|
Additional description: Dysgeusia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
20 / 168 (11.90%) |
30 / 170 (17.65%) |
occurrences all number
|
39 |
48 |
Hypertonia
|
|
|
Additional description: Hypertonia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hypoaesthesia
|
|
|
Additional description: Hypoaesthesia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
1 |
4 |
Hypoaesthesia oral
|
|
|
Additional description: Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Intercostal neuralgia
|
|
|
Additional description: Intercostal neuralgia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Loss of consciousness
|
|
|
Additional description: Loss of consciousness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Muscle spasticity
|
|
|
Additional description: Muscle spasticity
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Memory impairment
|
|
|
Additional description: Memory impairment
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Migraine
|
|
|
Additional description: Migraine
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Neuralgia
|
|
|
Additional description: Neuralgia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Neuropathy peripheral
|
|
|
Additional description: Neuropathy peripheral
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
8 / 170 (4.71%) |
occurrences all number
|
1 |
12 |
Paraparesis
|
|
|
Additional description: Paraparesis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Parkinson's disease
|
|
|
Additional description: Parkinson's disease
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Parosmia
|
|
|
Additional description: Parosmia
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Polyneuropathy
|
|
|
Additional description: Polyneuropathy
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
6 / 170 (3.53%) |
occurrences all number
|
2 |
6 |
Radiculopathy
|
|
|
Additional description: Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Sciatica
|
|
|
Additional description: Sciatica
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Syncope
|
|
|
Additional description: Syncope
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Tremor
|
|
|
Additional description: Tremor
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Vascular encephalopathy
|
|
|
Additional description: Vascular encephalopathy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
4 / 170 (2.35%) |
occurrences all number
|
4 |
4 |
Coagulopathy
|
|
|
Additional description: Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Eosinophilia
|
|
|
Additional description: Eosinophilia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Haemorrhagic diathesis
|
|
|
Additional description: Haemorrhagic diathesis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Immune thrombocytopenia
|
|
|
Additional description: Immune thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Iron deficiency anaemia
|
|
|
Additional description: Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Leukocytosis
|
|
|
Additional description: Leukocytosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Lymph node pain
|
|
|
Additional description: Lymph node pain
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Lymphadenopathy
|
|
|
Additional description: Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Neutropenia
|
|
|
Additional description: Neutropenia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
3 |
Splenomegaly
|
|
|
Additional description: Splenomegaly
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Thrombocytopenia
|
|
|
Additional description: Thrombocytopenia
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
5 / 170 (2.94%) |
occurrences all number
|
4 |
5 |
Ear and labyrinth disorders
|
|
|
Ear disorder
|
|
|
Additional description: Ear disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Ear discomfort
|
|
|
Additional description: Ear discomfort
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Ear pain
|
|
|
Additional description: Ear pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Ear pruritus
|
|
|
Additional description: Ear pruritus
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Ear swelling
|
|
|
Additional description: Ear swelling
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Ear haemorrhage
|
|
|
Additional description: Ear haemorrhage
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperacusis
|
|
|
Additional description: Hyperacusis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Sudden hearing loss
|
|
|
Additional description: Sudden hearing loss
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tinnitus
|
|
|
Additional description: Tinnitus
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
8 / 168 (4.76%) |
12 / 170 (7.06%) |
occurrences all number
|
8 |
17 |
Vertigo positional
|
|
|
Additional description: Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Eye disorders
|
|
|
Blepharitis
|
|
|
Additional description: Blepharitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blepharospasm
|
|
|
Additional description: Blepharospasm
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blindness
|
|
|
Additional description: Blindness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cataract
|
|
|
Additional description: Cataract
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
6 / 170 (3.53%) |
occurrences all number
|
2 |
6 |
Conjunctival haemorrhage
|
|
|
Additional description: Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Dacryostenosis acquired
|
|
|
Additional description: Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Diplopia
|
|
|
Additional description: Diplopia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dry eye
|
|
|
Additional description: Dry eye
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Eye haematoma
|
|
|
Additional description: Eye haematoma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Eye inflammation
|
|
|
Additional description: Eye inflammation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Eye pruritus
|
|
|
Additional description: Eye pruritus
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Glaucoma
|
|
|
Additional description: Glaucoma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Macular degeneration
|
|
|
Additional description: Macular degeneration
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Macular oedema
|
|
|
Additional description: Macular oedema
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Posterior capsule opacification
|
|
|
Additional description: Posterior capsule opacification
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Vision blurred
|
|
|
Additional description: Vision blurred
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Visual acuity reduced
|
|
|
Additional description: Visual acuity reduced
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Visual impairment
|
|
|
Additional description: Visual impairment
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Gastrointestinal disorders
|
|
|
Abdominal pain lower
|
|
|
Additional description: Abdominal pain lower
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
11 / 168 (6.55%) |
6 / 170 (3.53%) |
occurrences all number
|
12 |
8 |
Abdominal distension
|
|
|
Additional description: Abdominal distension
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Abdominal discomfort
|
|
|
Additional description: Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
13 / 168 (7.74%) |
11 / 170 (6.47%) |
occurrences all number
|
14 |
12 |
Angular cheilitis
|
|
|
Additional description: Angular cheilitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Anal inflammation
|
|
|
Additional description: Anal inflammation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Anal fistula
|
|
|
Additional description: Anal fistula
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Aphthous ulcer
|
|
|
Additional description: Aphthous ulcer
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Ascites
|
|
|
Additional description: Ascites
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cheilitis
|
|
|
Additional description: Cheilitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Chronic gastritis
|
|
|
Additional description: Chronic gastritis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Constipation
|
|
|
Additional description: Constipation
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
9 / 170 (5.29%) |
occurrences all number
|
9 |
9 |
Dental caries
|
|
|
Additional description: Dental caries
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
31 / 168 (18.45%) |
58 / 170 (34.12%) |
occurrences all number
|
48 |
101 |
Diarrhoea haemorrhagic
|
|
|
Additional description: Diarrhoea haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Diverticulum
|
|
|
Additional description: Diverticulum
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Diverticulum intestinal
|
|
|
Additional description: Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Dry mouth
|
|
|
Additional description: Dry mouth
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
14 / 170 (8.24%) |
occurrences all number
|
7 |
15 |
Dyspepsia
|
|
|
Additional description: Dyspepsia
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
27 / 170 (15.88%) |
occurrences all number
|
7 |
66 |
Dysphagia
|
|
|
Additional description: Dysphagia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Epigastric discomfort
|
|
|
Additional description: Epigastric discomfort
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Eructation
|
|
|
Additional description: Eructation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastric disorder
|
|
|
Additional description: Gastric disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Flatulence
|
|
|
Additional description: Flatulence
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
4 / 170 (2.35%) |
occurrences all number
|
3 |
5 |
Frequent bowel movements
|
|
|
Additional description: Frequent bowel movements
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Glossodynia
|
|
|
Additional description: Glossodynia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastritis
|
|
|
Additional description: Gastritis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
7 / 170 (4.12%) |
occurrences all number
|
0 |
7 |
Gastrointestinal disorder
|
|
|
Additional description: Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Gastrointestinal pain
|
|
|
Additional description: Gastrointestinal pain
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
7 / 170 (4.12%) |
occurrences all number
|
2 |
7 |
Gingival bleeding
|
|
|
Additional description: Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
3 |
Gingival disorder
|
|
|
Additional description: Gingival disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gingival swelling
|
|
|
Additional description: Gingival swelling
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gingivitis ulcerative
|
|
|
Additional description: Gingivitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Glossitis
|
|
|
Additional description: Glossitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
7 |
Gastric ulcer
|
|
|
Additional description: Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Haematochezia
|
|
|
Additional description: Haematochezia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
3 |
Haemorrhoids
|
|
|
Additional description: Haemorrhoids
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
2 / 170 (1.18%) |
occurrences all number
|
5 |
2 |
Haemorrhoids thrombosed
|
|
|
Additional description: Haemorrhoids thrombosed
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hiatus hernia
|
|
|
Additional description: Hiatus hernia
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
2 / 170 (1.18%) |
occurrences all number
|
3 |
2 |
Intestinal polyp
|
|
|
Additional description: Intestinal polyp
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Large intestine polyp
|
|
|
Additional description: Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Lip blister
|
|
|
Additional description: Lip blister
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Loose tooth
|
|
|
Additional description: Loose tooth
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Mouth swelling
|
|
|
Additional description: Mouth swelling
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Mouth ulceration
|
|
|
Additional description: Mouth ulceration
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
4 |
Melaena
|
|
|
Additional description: Melaena
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Mouth haemorrhage
|
|
|
Additional description: Mouth haemorrhage
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
20 / 168 (11.90%) |
32 / 170 (18.82%) |
occurrences all number
|
30 |
57 |
Noninfective gingivitis
|
|
|
Additional description: Noninfective gingivitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Obstruction gastric
|
|
|
Additional description: Obstruction gastric
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Oesophageal pain
|
|
|
Additional description: Oesophageal pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oesophagitis
|
|
|
Additional description: Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oral disorder
|
|
|
Additional description: Oral disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oral pain
|
|
|
Additional description: Oral pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pancreatic cyst
|
|
|
Additional description: Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Paraesthesia oral
|
|
|
Additional description: Paraesthesia oral
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Proctitis
|
|
|
Additional description: Proctitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Rectal prolapse
|
|
|
Additional description: Rectal prolapse
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Salivary gland enlargement
|
|
|
Additional description: Salivary gland enlargement
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Stomatitis
|
|
|
Additional description: Stomatitis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
13 / 170 (7.65%) |
occurrences all number
|
2 |
20 |
Subileus
|
|
|
Additional description: Subileus
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Tongue blistering
|
|
|
Additional description: Tongue blistering
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tongue ulceration
|
|
|
Additional description: Tongue ulceration
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Toothache
|
|
|
Additional description: Toothache
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
3 / 170 (1.76%) |
occurrences all number
|
3 |
4 |
Umbilical hernia
|
|
|
Additional description: Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Vomiting
|
|
|
Additional description: Vomiting
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
13 / 170 (7.65%) |
occurrences all number
|
9 |
16 |
Hepatobiliary disorders
|
|
|
Cholecystitis acute
|
|
|
Additional description: Cholecystitis acute
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cholelithiasis
|
|
|
Additional description: Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Hepatic cyst
|
|
|
Additional description: Hepatic cyst
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hepatic steatosis
|
|
|
Additional description: Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Hyperbilirubinaemia
|
|
|
Additional description: Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin and subcutaneous tissue disorders
|
|
|
Actinic keratosis
|
|
|
Additional description: Actinic keratosis
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
2 / 170 (1.18%) |
occurrences all number
|
4 |
4 |
Alopecia areata
|
|
|
Additional description: Alopecia areata
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Alopecia
|
|
|
Additional description: Alopecia
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
5 / 170 (2.94%) |
occurrences all number
|
4 |
5 |
Asteatosis
|
|
|
Additional description: Asteatosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Blood blister
|
|
|
Additional description: Blood blister
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Butterfly rash
|
|
|
Additional description: Butterfly rash
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dandruff
|
|
|
Additional description: Dandruff
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dermatitis
|
|
|
Additional description: Dermatitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Dermatitis acneiform
|
|
|
Additional description: Dermatitis acneiform
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
5 |
Dermatitis allergic
|
|
|
Additional description: Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Dermatitis atopic
|
|
|
Additional description: Dermatitis atopic
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Dermatitis bullous
|
|
|
Additional description: Dermatitis bullous
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Dermatosis
|
|
|
Additional description: Dermatosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Dermal cyst
|
|
|
Additional description: Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
3 |
Ecchymosis
|
|
|
Additional description: Ecchymosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
3 |
Eczema
|
|
|
Additional description: Eczema
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
7 / 170 (4.12%) |
occurrences all number
|
1 |
9 |
Drug eruption
|
|
|
Additional description: Drug eruption
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dry skin
|
|
|
Additional description: Dry skin
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
16 / 170 (9.41%) |
occurrences all number
|
5 |
19 |
Erythema
|
|
|
Additional description: Erythema
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
3 |
Haemorrhage subcutaneous
|
|
|
Additional description: Haemorrhage subcutaneous
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hair colour changes
|
|
|
Additional description: Hair colour changes
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hair growth abnormal
|
|
|
Additional description: Hair growth abnormal
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hyperhidrosis
|
|
|
Additional description: Hyperhidrosis
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
4 / 170 (2.35%) |
occurrences all number
|
10 |
4 |
Hyperkeratosis
|
|
|
Additional description: Hyperkeratosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Ingrowing nail
|
|
|
Additional description: Ingrowing nail
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
5 / 170 (2.94%) |
occurrences all number
|
0 |
5 |
Nail atrophy
|
|
|
Additional description: Nail atrophy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Nail bed inflammation
|
|
|
Additional description: Nail bed inflammation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Nail disorder
|
|
|
Additional description: Nail disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Nail dystrophy
|
|
|
Additional description: Nail dystrophy
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Nail ridging
|
|
|
Additional description: Nail ridging
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
4 / 170 (2.35%) |
occurrences all number
|
0 |
4 |
Night sweats
|
|
|
Additional description: Night sweats
|
|
|
subjects affected / exposed
|
9 / 168 (5.36%) |
5 / 170 (2.94%) |
occurrences all number
|
14 |
7 |
Onychoclasis
|
|
|
Additional description: Onychoclasis
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
19 / 170 (11.18%) |
occurrences all number
|
3 |
19 |
Onycholysis
|
|
|
Additional description: Onycholysis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pain of skin
|
|
|
Additional description: Pain of skin
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Petechiae
|
|
|
Additional description: Petechiae
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
7 / 170 (4.12%) |
occurrences all number
|
0 |
9 |
Photosensitivity reaction
|
|
|
Additional description: Photosensitivity reaction
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Polymorphic light eruption
|
|
|
Additional description: Polymorphic light eruption
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pruritus
|
|
|
Additional description: Pruritus
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
13 / 170 (7.65%) |
occurrences all number
|
7 |
15 |
Psoriasis
|
|
|
Additional description: Psoriasis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Purpura
|
|
|
Additional description: Purpura
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Rash
|
|
|
Additional description: Rash
|
|
|
subjects affected / exposed
|
10 / 168 (5.95%) |
33 / 170 (19.41%) |
occurrences all number
|
15 |
44 |
Rash erythematous
|
|
|
Additional description: Rash erythematous
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Rash maculo-papular
|
|
|
Additional description: Rash maculo-papular
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
9 |
Rash papular
|
|
|
Additional description: Rash papular
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Scalp disorder
|
|
|
Additional description: Scalp disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Seborrhoeic dermatitis
|
|
|
Additional description: Seborrhoeic dermatitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin discolouration
|
|
|
Additional description: Skin discolouration
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin disorder
|
|
|
Additional description: Skin disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin erosion
|
|
|
Additional description: Skin erosion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin fissures
|
|
|
Additional description: Skin fissures
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
8 / 170 (4.71%) |
occurrences all number
|
0 |
10 |
Skin haemorrhage
|
|
|
Additional description: Skin haemorrhage
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Skin hyperpigmentation
|
|
|
Additional description: Skin hyperpigmentation
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Skin induration
|
|
|
Additional description: Skin induration
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin irritation
|
|
|
Additional description: Skin irritation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Skin lesion
|
|
|
Additional description: Skin lesion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Skin sensitisation
|
|
|
Additional description: Skin sensitisation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Skin ulcer
|
|
|
Additional description: Skin ulcer
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Swelling face
|
|
|
Additional description: Swelling face
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Urticaria
|
|
|
Additional description: Urticaria
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Renal and urinary disorders
|
|
|
Chromaturia
|
|
|
Additional description: Chromaturia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Cystitis noninfective
|
|
|
Additional description: Cystitis noninfective
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dysuria
|
|
|
Additional description: Dysuria
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
3 |
Haematuria
|
|
|
Additional description: Haematuria
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
6 / 170 (3.53%) |
occurrences all number
|
4 |
9 |
Incontinence
|
|
|
Additional description: Incontinence
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Micturition urgency
|
|
|
Additional description: Micturition urgency
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Nocturia
|
|
|
Additional description: Nocturia
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Pollakiuria
|
|
|
Additional description: Pollakiuria
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
0 / 170 (0.00%) |
occurrences all number
|
6 |
0 |
Renal cyst
|
|
|
Additional description: Renal cyst
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Renal failure
|
|
|
Additional description: Renal failure
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Renal pain
|
|
|
Additional description: Renal pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Urinary incontinence
|
|
|
Additional description: Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Endocrine disorders
|
|
|
Goitre
|
|
|
Additional description: Goitre
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hashimoto's disease
|
|
|
Additional description: Hashimoto's disease
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperparathyroidism
|
|
|
Additional description: Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hyperparathyroidism secondary
|
|
|
Additional description: Hyperparathyroidism secondary
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hypogonadism
|
|
|
Additional description: Hypogonadism
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Thyroid calcification
|
|
|
Additional description: Thyroid calcification
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Thyroid mass
|
|
|
Additional description: Thyroid mass
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Type 2 diabetes mellitus
|
|
|
Additional description: Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
15 / 168 (8.93%) |
30 / 170 (17.65%) |
occurrences all number
|
18 |
37 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Arthritis reactive
|
|
|
Additional description: Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Arthropathy
|
|
|
Additional description: Arthropathy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
20 / 168 (11.90%) |
20 / 170 (11.76%) |
occurrences all number
|
24 |
24 |
Barrel chest
|
|
|
Additional description: Barrel chest
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bone pain
|
|
|
Additional description: Bone pain
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Bursitis
|
|
|
Additional description: Bursitis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Collagen disorder
|
|
|
Additional description: Collagen disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Exostosis
|
|
|
Additional description: Exostosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Flank pain
|
|
|
Additional description: Flank pain
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Foot deformity
|
|
|
Additional description: Foot deformity
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Groin pain
|
|
|
Additional description: Groin pain
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercreatinaemia
|
|
|
Additional description: Hypercreatinaemia
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Joint effusion
|
|
|
Additional description: Joint effusion
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Joint swelling
|
|
|
Additional description: Joint swelling
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Intervertebral disc disorder
|
|
|
Additional description: Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Intervertebral disc protrusion
|
|
|
Additional description: Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Jaw cyst
|
|
|
Additional description: Jaw cyst
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Limb discomfort
|
|
|
Additional description: Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle atrophy
|
|
|
Additional description: Muscle atrophy
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle spasms
|
|
|
Additional description: Muscle spasms
|
|
|
subjects affected / exposed
|
6 / 168 (3.57%) |
25 / 170 (14.71%) |
occurrences all number
|
9 |
52 |
Muscle twitching
|
|
|
Additional description: Muscle twitching
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Muscular weakness
|
|
|
Additional description: Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
3 |
3 |
Musculoskeletal chest pain
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Musculoskeletal disorder
|
|
|
Additional description: Musculoskeletal disorder
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Musculoskeletal pain
|
|
|
Additional description: Musculoskeletal pain
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
4 / 170 (2.35%) |
occurrences all number
|
6 |
5 |
Musculoskeletal stiffness
|
|
|
Additional description: Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Myalgia
|
|
|
Additional description: Myalgia
|
|
|
subjects affected / exposed
|
8 / 168 (4.76%) |
12 / 170 (7.06%) |
occurrences all number
|
9 |
12 |
Myositis
|
|
|
Additional description: Myositis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Neck pain
|
|
|
Additional description: Neck pain
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
2 / 170 (1.18%) |
occurrences all number
|
4 |
2 |
Muscle tightness
|
|
|
Additional description: Muscle tightness
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
3 / 170 (1.76%) |
occurrences all number
|
1 |
3 |
Osteoporosis
|
|
|
Additional description: Osteoporosis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
15 / 168 (8.93%) |
15 / 170 (8.82%) |
occurrences all number
|
17 |
21 |
Pain in jaw
|
|
|
Additional description: Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Osteoarthritis
|
|
|
Additional description: Osteoarthritis
|
|
|
subjects affected / exposed
|
11 / 168 (6.55%) |
3 / 170 (1.76%) |
occurrences all number
|
11 |
4 |
Periarthritis
|
|
|
Additional description: Periarthritis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Periostitis
|
|
|
Additional description: Periostitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Plantar fasciitis
|
|
|
Additional description: Plantar fasciitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Plica syndrome
|
|
|
Additional description: Plica syndrome
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Rheumatic disorder
|
|
|
Additional description: Rheumatic disorder
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal osteoarthritis
|
|
|
Additional description: Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Spinal pain
|
|
|
Additional description: Spinal pain
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Spinal stenosis
|
|
|
Additional description: Spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Synovial cyst
|
|
|
Additional description: Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Tendon discomfort
|
|
|
Additional description: Tendon discomfort
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Tenosynovitis
|
|
|
Additional description: Tenosynovitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Torticollis
|
|
|
Additional description: Torticollis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Infections and infestations
|
|
|
Acne pustular
|
|
|
Additional description: Acne pustular
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Abscess limb
|
|
|
Additional description: Abscess limb
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Abscess
|
|
|
Additional description: Abscess
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Angular cheilitis
|
|
|
Additional description: Angular cheilitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Alveolar osteitis
|
|
|
Additional description: Alveolar osteitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial diarrhoea
|
|
|
Additional description: Bacterial diarrhoea
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Arthritis infective
|
|
|
Additional description: Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Atypical pneumonia
|
|
|
Additional description: Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Bacterial rhinitis
|
|
|
Additional description: Bacterial rhinitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Bacterial vaginosis
|
|
|
Additional description: Bacterial vaginosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial food poisoning
|
|
|
Additional description: Bacterial food poisoning
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial infection
|
|
|
Additional description: Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Bacterial pyelonephritis
|
|
|
Additional description: Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Bronchitis
|
|
|
Additional description: Bronchitis
|
|
|
subjects affected / exposed
|
19 / 168 (11.31%) |
26 / 170 (15.29%) |
occurrences all number
|
21 |
30 |
Bronchitis bacterial
|
|
|
Additional description: Bronchitis bacterial
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Bronchitis viral
|
|
|
Additional description: Bronchitis viral
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Bursitis infective
|
|
|
Additional description: Bursitis infective
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Campylobacter infection
|
|
|
Additional description: Campylobacter infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Candida infection
|
|
|
Additional description: Candida infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Chronic tonsillitis
|
|
|
Additional description: Chronic tonsillitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Chronic sinusitis
|
|
|
Additional description: Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Cellulitis
|
|
|
Additional description: Cellulitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Conjunctivitis
|
|
|
Additional description: Conjunctivitis
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
6 / 170 (3.53%) |
occurrences all number
|
3 |
9 |
COVID-19
|
|
|
Additional description: COVID-19
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
7 / 170 (4.12%) |
occurrences all number
|
7 |
7 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
12 / 168 (7.14%) |
10 / 170 (5.88%) |
occurrences all number
|
20 |
21 |
Cystitis bacterial
|
|
|
Additional description: Cystitis bacterial
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Dermatitis infected
|
|
|
Additional description: Dermatitis infected
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
0 / 170 (0.00%) |
occurrences all number
|
3 |
0 |
Diarrhoea infectious
|
|
|
Additional description: Diarrhoea infectious
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Diverticulitis
|
|
|
Additional description: Diverticulitis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
4 |
1 |
Ear infection
|
|
|
Additional description: Ear infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Epididymitis
|
|
|
Additional description: Epididymitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
6 |
Erysipelas
|
|
|
Additional description: Erysipelas
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Eye infection
|
|
|
Additional description: Eye infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Eyelid infection
|
|
|
Additional description: Eyelid infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Enterococcal infection
|
|
|
Additional description: Enterococcal infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Febrile infection
|
|
|
Additional description: Febrile infection
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Folliculitis
|
|
|
Additional description: Folliculitis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
3 / 170 (1.76%) |
occurrences all number
|
2 |
3 |
Fungal infection
|
|
|
Additional description: Fungal infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Fungal pharyngitis
|
|
|
Additional description: Fungal pharyngitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Fungal skin infection
|
|
|
Additional description: Fungal skin infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Gastric infection
|
|
|
Additional description: Gastric infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
5 / 170 (2.94%) |
occurrences all number
|
6 |
7 |
Gastroenteritis norovirus
|
|
|
Additional description: Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastroenteritis viral
|
|
|
Additional description: Gastroenteritis viral
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastrointestinal candidiasis
|
|
|
Additional description: Gastrointestinal candidiasis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gastrointestinal infection
|
|
|
Additional description: Gastrointestinal infection
|
|
|
subjects affected / exposed
|
13 / 168 (7.74%) |
15 / 170 (8.82%) |
occurrences all number
|
14 |
26 |
Genital herpes
|
|
|
Additional description: Genital herpes
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Genital herpes zoster
|
|
|
Additional description: Genital herpes zoster
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Gingivitis
|
|
|
Additional description: Gingivitis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Haemophilus infection
|
|
|
Additional description: Haemophilus infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Helicobacter gastritis
|
|
|
Additional description: Helicobacter gastritis
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
2 / 170 (1.18%) |
occurrences all number
|
2 |
2 |
Hepatitis E
|
|
|
Additional description: Hepatitis E
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Herpes simplex
|
|
|
Additional description: Herpes simplex
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
3 |
0 |
Herpes virus infection
|
|
|
Additional description: Herpes virus infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
10 / 168 (5.95%) |
5 / 170 (2.94%) |
occurrences all number
|
13 |
5 |
Hepatitis viral
|
|
|
Additional description: Hepatitis viral
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Impetigo
|
|
|
Additional description: Impetigo
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Infected bite
|
|
|
Additional description: Infected bite
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
0 / 170 (0.00%) |
occurrences all number
|
3 |
0 |
Infected bites
|
|
|
Additional description: Infected bites
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Infected cyst
|
|
|
Additional description: Infected cyst
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Infection
|
|
|
Additional description: Infection
|
|
|
subjects affected / exposed
|
12 / 168 (7.14%) |
9 / 170 (5.29%) |
occurrences all number
|
13 |
14 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
8 / 168 (4.76%) |
12 / 170 (7.06%) |
occurrences all number
|
13 |
22 |
Injection site abscess
|
|
|
Additional description: Injection site abscess
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Laryngitis
|
|
|
Additional description: Laryngitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
4 / 170 (2.35%) |
occurrences all number
|
0 |
4 |
Lip infection
|
|
|
Additional description: Lip infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
4 |
Localised infection
|
|
|
Additional description: Localised infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Lower respiratory tract infection
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Lyme disease
|
|
|
Additional description: Lyme disease
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Mucosal infection
|
|
|
Additional description: Mucosal infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
2 |
Nail bed infection
|
|
|
Additional description: Nail bed infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Nail infection
|
|
|
Additional description: Nail infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Nasal herpes
|
|
|
Additional description: Nasal herpes
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Nasopharyngitis
|
|
|
Additional description: Nasopharyngitis
|
|
|
subjects affected / exposed
|
72 / 168 (42.86%) |
51 / 170 (30.00%) |
occurrences all number
|
126 |
108 |
Neutropenic infection
|
|
|
Additional description: Neutropenic infection
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
0 / 170 (0.00%) |
occurrences all number
|
2 |
0 |
Nosocomial infection
|
|
|
Additional description: Nosocomial infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Onychomycosis
|
|
|
Additional description: Onychomycosis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Oral fungal infection
|
|
|
Additional description: Oral fungal infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Oral herpes
|
|
|
Additional description: Oral herpes
|
|
|
subjects affected / exposed
|
12 / 168 (7.14%) |
2 / 170 (1.18%) |
occurrences all number
|
18 |
6 |
Oral infection
|
|
|
Additional description: Oral infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Oral viral infection
|
|
|
Additional description: Oral viral infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Orchitis
|
|
|
Additional description: Orchitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Otitis externa
|
|
|
Additional description: Otitis externa
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Paronychia
|
|
|
Additional description: Paronychia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
10 / 170 (5.88%) |
occurrences all number
|
3 |
12 |
Parotitis
|
|
|
Additional description: Parotitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
3 |
1 |
Penile infection
|
|
|
Additional description: Penile infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Periodontitis
|
|
|
Additional description: Periodontitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Pharyngitis
|
|
|
Additional description: Pharyngitis
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
4 / 170 (2.35%) |
occurrences all number
|
4 |
4 |
Phlebitis infective
|
|
|
Additional description: Phlebitis infective
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Pneumonia
|
|
|
Additional description: Pneumonia
|
|
|
subjects affected / exposed
|
7 / 168 (4.17%) |
10 / 170 (5.88%) |
occurrences all number
|
9 |
15 |
Postoperative wound infection
|
|
|
Additional description: Postoperative wound infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pseudomonas infection
|
|
|
Additional description: Pseudomonas infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Purulence
|
|
|
Additional description: Purulence
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pyelonephritis
|
|
|
Additional description: Pyelonephritis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Pyoderma
|
|
|
Additional description: Pyoderma
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Rash pustular
|
|
|
Additional description: Rash pustular
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Respiratory tract infection
|
|
|
Additional description: Respiratory tract infection
|
|
|
subjects affected / exposed
|
8 / 168 (4.76%) |
13 / 170 (7.65%) |
occurrences all number
|
9 |
23 |
Retinitis
|
|
|
Additional description: Retinitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Rhinitis
|
|
|
Additional description: Rhinitis
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
10 / 170 (5.88%) |
occurrences all number
|
5 |
10 |
Root canal infection
|
|
|
Additional description: Root canal infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
2 / 170 (1.18%) |
occurrences all number
|
1 |
2 |
Scarlet fever
|
|
|
Additional description: Scarlet fever
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Scrotal infection
|
|
|
Additional description: Scrotal infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
5 |
Seminal vesicular infection
|
|
|
Additional description: Seminal vesicular infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Sialoadenitis
|
|
|
Additional description: Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Sinobronchitis
|
|
|
Additional description: Sinobronchitis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
8 / 168 (4.76%) |
9 / 170 (5.29%) |
occurrences all number
|
11 |
15 |
Sinusitis bacterial
|
|
|
Additional description: Sinusitis bacterial
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Skin infection
|
|
|
Additional description: Skin infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
2 |
5 |
Subcutaneous abscess
|
|
|
Additional description: Subcutaneous abscess
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Tinea infection
|
|
|
Additional description: Tinea infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Tinea versicolour
|
|
|
Additional description: Tinea versicolour
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
17 / 168 (10.12%) |
19 / 170 (11.18%) |
occurrences all number
|
20 |
30 |
Tongue fungal infection
|
|
|
Additional description: Tongue fungal infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Tonsillitis
|
|
|
Additional description: Tonsillitis
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
3 / 170 (1.76%) |
occurrences all number
|
3 |
5 |
Tooth abscess
|
|
|
Additional description: Tooth abscess
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Tooth infection
|
|
|
Additional description: Tooth infection
|
|
|
subjects affected / exposed
|
4 / 168 (2.38%) |
3 / 170 (1.76%) |
occurrences all number
|
4 |
3 |
Tracheitis
|
|
|
Additional description: Tracheitis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Trichomoniasis
|
|
|
Additional description: Trichomoniasis
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
0 / 170 (0.00%) |
occurrences all number
|
1 |
0 |
Tinea pedis
|
|
|
Additional description: Tinea pedis
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
12 / 168 (7.14%) |
20 / 170 (11.76%) |
occurrences all number
|
14 |
41 |
Vulvovaginal mycotic infection
|
|
|
Additional description: Vulvovaginal mycotic infection
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Viral diarrhoea
|
|
|
Additional description: Viral diarrhoea
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Viral infection
|
|
|
Additional description: Viral infection
|
|
|
subjects affected / exposed
|
5 / 168 (2.98%) |
3 / 170 (1.76%) |
occurrences all number
|
5 |
3 |
Viral upper respiratory tract infection
|
|
|
Additional description: Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 168 (1.19%) |
1 / 170 (0.59%) |
occurrences all number
|
2 |
1 |
Wound infection bacterial
|
|
|
Additional description: Wound infection bacterial
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Wound infection
|
|
|
Additional description: Wound infection
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Wound infection pseudomonas
|
|
|
Additional description: Wound infection pseudomonas
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
Additional description: Decreased appetite
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
3 / 170 (1.76%) |
occurrences all number
|
5 |
3 |
Diabetes mellitus
|
|
|
Additional description: Diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Diabetic metabolic decompensation
|
|
|
Additional description: Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Folate deficiency
|
|
|
Additional description: Folate deficiency
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Gout
|
|
|
Additional description: Gout
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
6 / 170 (3.53%) |
occurrences all number
|
2 |
6 |
Hypercholesterolaemia
|
|
|
Additional description: Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
3 |
Hypercreatininaemia
|
|
|
Additional description: Hypercreatininaemia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Hyperglycaemia
|
|
|
Additional description: Hyperglycaemia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Hyperkalaemia
|
|
|
Additional description: Hyperkalaemia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Hyperlipasaemia
|
|
|
Additional description: Hyperlipasaemia
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
1 / 170 (0.59%) |
occurrences all number
|
1 |
1 |
Hyperuricaemia
|
|
|
Additional description: Hyperuricaemia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
3 / 170 (1.76%) |
occurrences all number
|
0 |
3 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Iron deficiency
|
|
|
Additional description: Iron deficiency
|
|
|
subjects affected / exposed
|
1 / 168 (0.60%) |
4 / 170 (2.35%) |
occurrences all number
|
1 |
4 |
Protein deficiency
|
|
|
Additional description: Protein deficiency
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Type 2 diabetes mellitus
|
|
|
Additional description: Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
2 / 170 (1.18%) |
occurrences all number
|
0 |
2 |
Vitamin B12 deficiency
|
|
|
Additional description: Vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
0 / 168 (0.00%) |
1 / 170 (0.59%) |
occurrences all number
|
0 |
1 |
Vitamin D deficiency
|
|
|
Additional description: Vitamin D deficiency
|
|
|
subjects affected / exposed
|
3 / 168 (1.79%) |
4 / 170 (2.35%) |
occurrences all number
|
3 |
4 |