Non-serious adverse events
|
AOP2014 |
Control |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
115 / 127 (90.55%) |
117 / 127 (92.13%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adrenal adenoma
|
|
|
Additional description: Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Angiolipoma
|
|
|
Additional description: Angiolipoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Adrenal neoplasm
|
|
|
Additional description: Adrenal neoplasm
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Angiomyolipoma
|
|
|
Additional description: Angiomyolipoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Benign neoplasm of thyroid gland
|
|
|
Additional description: Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Bile duct cancer
|
|
|
Additional description: Bile duct cancer
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Blepharal papilloma
|
|
|
Additional description: Blepharal papilloma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Colon adenoma
|
|
|
Additional description: Colon adenoma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Fibrous histiocytoma
|
|
|
Additional description: Fibrous histiocytoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Haemangioma of liver
|
|
|
Additional description: Haemangioma of liver
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Intestinal adenocarcinoma
|
|
|
Additional description: Intestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Keratoacanthoma
|
|
|
Additional description: Keratoacanthoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Lipoma
|
|
|
Additional description: Lipoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Myelofibrosis
|
|
|
Additional description: Myelofibrosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Primary myelofibrosis
|
|
|
Additional description: Primary myelofibrosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Prostate cancer
|
|
|
Additional description: Prostate cancer
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Prostatic adenoma
|
|
|
Additional description: Prostatic adenoma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Uterine leiomyoma
|
|
|
Additional description: Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Vascular disorders
|
|
|
Aneurysm
|
|
|
Additional description: Aneurysm
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Aortic stenosis
|
|
|
Additional description: Aortic stenosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Blood pressure fluctuation
|
|
|
Additional description: Blood pressure fluctuation
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Circulatory collapse
|
|
|
Additional description: Circulatory collapse
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Erythromelalgia
|
|
|
Additional description: Erythromelalgia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Femoral artery occlusion
|
|
|
Additional description: Femoral artery occlusion
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Haematoma
|
|
|
Additional description: Haematoma
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
4 / 127 (3.15%) |
occurrences all number
|
2 |
5 |
Hypertension
|
|
|
Additional description: Hypertension
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
12 / 127 (9.45%) |
occurrences all number
|
12 |
14 |
Hypertensive crisis
|
|
|
Additional description: Hypertensive crisis
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Hypotension
|
|
|
Additional description: Hypotension
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Peripheral arterial occlusive disease
|
|
|
Additional description: Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Peripheral artery stenosis
|
|
|
Additional description: Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral circulatory failure
|
|
|
Additional description: Peripheral circulatory failure
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Peripheral coldness
|
|
|
Additional description: Peripheral coldness
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Phlebitis
|
|
|
Additional description: Phlebitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Raynaud's phenomenon
|
|
|
Additional description: Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Subclavian steal syndrome
|
|
|
Additional description: Subclavian steal syndrome
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Thrombophlebitis
|
|
|
Additional description: Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Varicose vein
|
|
|
Additional description: Varicose vein
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular pain
|
|
|
Additional description: Vascular pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Venous thrombosis limb
|
|
|
Additional description: Venous thrombosis limb
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Surgical and medical procedures
|
|
|
Blepharoplasty
|
|
|
Additional description: Blepharoplasty
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Carpal tunnel decompression
|
|
|
Additional description: Carpal tunnel decompression
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cataract operation
|
|
|
Additional description: Cataract operation
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
5 / 127 (3.94%) |
occurrences all number
|
3 |
6 |
Endocervical curettage
|
|
|
Additional description: Endocervical curettage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eye operation
|
|
|
Additional description: Eye operation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Intraocular lens implant
|
|
|
Additional description: Intraocular lens implant
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Maxillofacial operation
|
|
|
Additional description: Maxillofacial operation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Ovarian cystectomy
|
|
|
Additional description: Ovarian cystectomy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral endarterectomy
|
|
|
Additional description: Peripheral endarterectomy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Polypectomy
|
|
|
Additional description: Polypectomy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Proctectomy
|
|
|
Additional description: Proctectomy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Prostatic operation
|
|
|
Additional description: Prostatic operation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Skin neoplasm excision
|
|
|
Additional description: Skin neoplasm excision
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Tooth extraction
|
|
|
Additional description: Tooth extraction
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
2 / 127 (1.57%) |
occurrences all number
|
7 |
2 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
Additional description: Asthenia
|
|
|
subjects affected / exposed
|
11 / 127 (8.66%) |
7 / 127 (5.51%) |
occurrences all number
|
20 |
24 |
Axillary pain
|
|
|
Additional description: Axillary pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Chest discomfort
|
|
|
Additional description: Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Chest pain
|
|
|
Additional description: Chest pain
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
1 / 127 (0.79%) |
occurrences all number
|
5 |
1 |
Chills
|
|
|
Additional description: Chills
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Condition aggravated
|
|
|
Additional description: Condition aggravated
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Cyst
|
|
|
Additional description: Cyst
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Drug intolerance
|
|
|
Additional description: Drug intolerance
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Facial pain
|
|
|
Additional description: Facial pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Fatigue
|
|
|
Additional description: Fatigue
|
|
|
subjects affected / exposed
|
17 / 127 (13.39%) |
21 / 127 (16.54%) |
occurrences all number
|
47 |
27 |
Feeling cold
|
|
|
Additional description: Feeling cold
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
3 |
Impaired healing
|
|
|
Additional description: Impaired healing
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Inflammation
|
|
|
Additional description: Inflammation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Influenza like illness
|
|
|
Additional description: Influenza like illness
|
|
|
subjects affected / exposed
|
10 / 127 (7.87%) |
3 / 127 (2.36%) |
occurrences all number
|
16 |
3 |
Injection site erythema
|
|
|
Additional description: Injection site erythema
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Injection site haematoma
|
|
|
Additional description: Injection site haematoma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Injection site pain
|
|
|
Additional description: Injection site pain
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Injection site pruritus
|
|
|
Additional description: Injection site pruritus
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Injection site reaction
|
|
|
Additional description: Injection site reaction
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Injection site warmth
|
|
|
Additional description: Injection site warmth
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Mucosal inflammation
|
|
|
Additional description: Mucosal inflammation
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
2 |
Non-cardiac chest pain
|
|
|
Additional description: Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Oedema peripheral
|
|
|
Additional description: Oedema peripheral
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
4 / 127 (3.15%) |
occurrences all number
|
5 |
4 |
Pain
|
|
|
Additional description: Pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
4 / 127 (3.15%) |
occurrences all number
|
1 |
5 |
Peripheral swelling
|
|
|
Additional description: Peripheral swelling
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Puncture site pain
|
|
|
Additional description: Puncture site pain
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Pyrexia
|
|
|
Additional description: Pyrexia
|
|
|
subjects affected / exposed
|
13 / 127 (10.24%) |
6 / 127 (4.72%) |
occurrences all number
|
21 |
7 |
Sensation of foreign body
|
|
|
Additional description: Sensation of foreign body
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Soft tissue inflammation
|
|
|
Additional description: Soft tissue inflammation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Thirst
|
|
|
Additional description: Thirst
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Immune system disorders
|
|
|
Allergy to arthropod sting
|
|
|
Additional description: Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Drug hypersensitivity
|
|
|
Additional description: Drug hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hypersensitivity
|
|
|
Additional description: Hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Sarcoidosis
|
|
|
Additional description: Sarcoidosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Seasonal allergy
|
|
|
Additional description: Seasonal allergy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Social circumstances
|
|
|
Stress at work
|
|
|
Additional description: Stress at work
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Reproductive system and breast disorders
|
|
|
Acquired phimosis
|
|
|
Additional description: Acquired phimosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Amenorrhoea
|
|
|
Additional description: Amenorrhoea
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Benign prostatic hyperplasia
|
|
|
Additional description: Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
0 / 127 (0.00%) |
occurrences all number
|
5 |
0 |
Breast disorder
|
|
|
Additional description: Breast disorder
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Breast pain
|
|
|
Additional description: Breast pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Endometrial dysplasia
|
|
|
Additional description: Endometrial dysplasia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Erectile dysfunction
|
|
|
Additional description: Erectile dysfunction
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Fibrocystic breast disease
|
|
|
Additional description: Fibrocystic breast disease
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Haematospermia
|
|
|
Additional description: Haematospermia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Metrorrhagia
|
|
|
Additional description: Metrorrhagia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Menstruation irregular
|
|
|
Additional description: Menstruation irregular
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Ovarian cyst
|
|
|
Additional description: Ovarian cyst
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Prostatitis
|
|
|
Additional description: Prostatitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Uterine cervical erosion
|
|
|
Additional description: Uterine cervical erosion
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Uterine haemorrhage
|
|
|
Additional description: Uterine haemorrhage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Vaginal haemorrhage
|
|
|
Additional description: Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Asthma
|
|
|
Additional description: Asthma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cough
|
|
|
Additional description: Cough
|
|
|
subjects affected / exposed
|
11 / 127 (8.66%) |
11 / 127 (8.66%) |
occurrences all number
|
19 |
12 |
Dysphonia
|
|
|
Additional description: Dysphonia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspnoea
|
|
|
Additional description: Dyspnoea
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
2 |
2 |
Dyspnoea exertional
|
|
|
Additional description: Dyspnoea exertional
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Epistaxis
|
|
|
Additional description: Epistaxis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Increased bronchial secretion
|
|
|
Additional description: Increased bronchial secretion
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Lung infiltration
|
|
|
Additional description: Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Oropharyngeal pain
|
|
|
Additional description: Oropharyngeal pain
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
3 / 127 (2.36%) |
occurrences all number
|
10 |
3 |
Pneumonitis
|
|
|
Additional description: Pneumonitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Pulmonary hypertension
|
|
|
Additional description: Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Pulmonary microemboli
|
|
|
Additional description: Pulmonary microemboli
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Rales
|
|
|
Additional description: Rales
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Rhinitis allergic
|
|
|
Additional description: Rhinitis allergic
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Rhinitis atrophic
|
|
|
Additional description: Rhinitis atrophic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Sneezing
|
|
|
Additional description: Sneezing
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Throat irritation
|
|
|
Additional description: Throat irritation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Psychiatric disorders
|
|
|
Affective disorder
|
|
|
Additional description: Affective disorder
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Agitation
|
|
|
Additional description: Agitation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Anxiety
|
|
|
Additional description: Anxiety
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
4 / 127 (3.15%) |
occurrences all number
|
8 |
4 |
Anxiety disorder
|
|
|
Additional description: Anxiety disorder
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Apathy
|
|
|
Additional description: Apathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Depressed mood
|
|
|
Additional description: Depressed mood
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Depression
|
|
|
Additional description: Depression
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
4 / 127 (3.15%) |
occurrences all number
|
3 |
4 |
Emotional distress
|
|
|
Additional description: Emotional distress
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Hallucination
|
|
|
Additional description: Hallucination
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Insomnia
|
|
|
Additional description: Insomnia
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
7 / 127 (5.51%) |
occurrences all number
|
4 |
9 |
Irritability
|
|
|
Additional description: Irritability
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Libido increased
|
|
|
Additional description: Libido increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
3 |
Mood altered
|
|
|
Additional description: Mood altered
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Mood swings
|
|
|
Additional description: Mood swings
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Nervousness
|
|
|
Additional description: Nervousness
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Panic attack
|
|
|
Additional description: Panic attack
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Restlessness
|
|
|
Additional description: Restlessness
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Sleep disorder
|
|
|
Additional description: Sleep disorder
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Hepatobiliary disorders
|
|
|
Biliary colic
|
|
|
Additional description: Biliary colic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cholecystitis
|
|
|
Additional description: Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cholecystitis chronic
|
|
|
Additional description: Cholecystitis chronic
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Cholelithiasis
|
|
|
Additional description: Cholelithiasis
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
3 / 127 (2.36%) |
occurrences all number
|
4 |
3 |
Gallbladder cholesterolosis
|
|
|
Additional description: Gallbladder cholesterolosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gallbladder disorder
|
|
|
Additional description: Gallbladder disorder
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Gallbladder polyp
|
|
|
Additional description: Gallbladder polyp
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hepatic cyst
|
|
|
Additional description: Hepatic cyst
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Hepatic steatosis
|
|
|
Additional description: Hepatic steatosis
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Hepatitis toxic
|
|
|
Additional description: Hepatitis toxic
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Hepatomegaly
|
|
|
Additional description: Hepatomegaly
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Hepatosplenomegaly
|
|
|
Additional description: Hepatosplenomegaly
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hyperbilirubinaemia
|
|
|
Additional description: Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Liver disorder
|
|
|
Additional description: Liver disorder
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Pneumobilia
|
|
|
Additional description: Pneumobilia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Portal hypertension
|
|
|
Additional description: Portal hypertension
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Steatohepatitis
|
|
|
Additional description: Steatohepatitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
Additional description: Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
19 / 127 (14.96%) |
2 / 127 (1.57%) |
occurrences all number
|
40 |
2 |
Anti-thyroid antibody positive
|
|
|
Additional description: Anti-thyroid antibody positive
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
6 |
0 |
Antinuclear antibody increased
|
|
|
Additional description: Antinuclear antibody increased
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
3 / 127 (2.36%) |
occurrences all number
|
4 |
3 |
Aspartate aminotransferase increased
|
|
|
Additional description: Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
17 / 127 (13.39%) |
2 / 127 (1.57%) |
occurrences all number
|
27 |
2 |
Blood alkaline phosphatase increased
|
|
|
Additional description: Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
6 |
1 |
Blood bilirubin increased
|
|
|
Additional description: Blood bilirubin increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Blood creatine phosphokinase increased
|
|
|
Additional description: Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Blood creatinine increased
|
|
|
Additional description: Blood creatinine increased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
6 |
1 |
Blood fibrinogen decreased
|
|
|
Additional description: Blood fibrinogen decreased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Blood glucose increased
|
|
|
Additional description: Blood glucose increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
3 / 127 (2.36%) |
occurrences all number
|
0 |
3 |
Blood iron decreased
|
|
|
Additional description: Blood iron decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
4 / 127 (3.15%) |
occurrences all number
|
1 |
4 |
Blood lactate dehydrogenase increased
|
|
|
Additional description: Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
2 / 127 (1.57%) |
occurrences all number
|
4 |
2 |
Blood phosphorus decreased
|
|
|
Additional description: Blood phosphorus decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Blood potassium increased
|
|
|
Additional description: Blood potassium increased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Blood potassium decreased
|
|
|
Additional description: Blood potassium decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Blood pressure abnormal
|
|
|
Additional description: Blood pressure abnormal
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Blood pressure diastolic increased
|
|
|
Additional description: Blood pressure diastolic increased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Blood pressure systolic increased
|
|
|
Additional description: Blood pressure systolic increased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Blood pressure increased
|
|
|
Additional description: Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
2 |
Blood thyroid stimulating hormone increased
|
|
|
Additional description: Blood thyroid stimulating hormone increased
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
1 / 127 (0.79%) |
occurrences all number
|
6 |
4 |
Blood triglycerides increased
|
|
|
Additional description: Blood triglycerides increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Blood urea increased
|
|
|
Additional description: Blood urea increased
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
7 |
1 |
Blood uric acid increased
|
|
|
Additional description: Blood uric acid increased
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
2 / 127 (1.57%) |
occurrences all number
|
4 |
2 |
Body temperature decreased
|
|
|
Additional description: Body temperature decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Body temperature increased
|
|
|
Additional description: Body temperature increased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Colonoscopy
|
|
|
Additional description: Colonoscopy
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Computerised tomogram
|
|
|
Additional description: Computerised tomogram
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Eastern Cooperative Oncology Group performance status worsened
|
|
|
Additional description: Eastern Cooperative Oncology Group performance status worsened
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Electrocardiogram PR prolongation
|
|
|
Additional description: Electrocardiogram PR prolongation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Ejection fraction decreased
|
|
|
Additional description: Ejection fraction decreased
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Electrocardiogram QT interval abnormal
|
|
|
Additional description: Electrocardiogram QT interval abnormal
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Electrocardiogram QT prolonged
|
|
|
Additional description: Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Endoscopy upper gastrointestinal tract
|
|
|
Additional description: Endoscopy upper gastrointestinal tract
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
Additional description: Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
28 / 127 (22.05%) |
5 / 127 (3.94%) |
occurrences all number
|
91 |
5 |
Haematocrit decreased
|
|
|
Additional description: Haematocrit decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
4 / 127 (3.15%) |
occurrences all number
|
1 |
5 |
Haematocrit increased
|
|
|
Additional description: Haematocrit increased
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
5 / 127 (3.94%) |
occurrences all number
|
11 |
7 |
Haemoglobin decreased
|
|
|
Additional description: Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hepatic enzyme increased
|
|
|
Additional description: Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
8 / 127 (6.30%) |
1 / 127 (0.79%) |
occurrences all number
|
16 |
2 |
Lipase increased
|
|
|
Additional description: Lipase increased
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
7 |
2 |
Lymphocyte count decreased
|
|
|
Additional description: Lymphocyte count decreased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Magnetic resonance imaging
|
|
|
Additional description: Magnetic resonance imaging
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Mean cell volume increased
|
|
|
Additional description: Mean cell volume increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Neutrophil count increased
|
|
|
Additional description: Neutrophil count increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Nitrite urine present
|
|
|
Additional description: Nitrite urine present
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Platelet count decreased
|
|
|
Additional description: Platelet count decreased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
12 / 127 (9.45%) |
occurrences all number
|
5 |
21 |
Platelet count increased
|
|
|
Additional description: Platelet count increased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Scan with contrast
|
|
|
Additional description: Scan with contrast
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Serum ferritin decreased
|
|
|
Additional description: Serum ferritin decreased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Transaminases increased
|
|
|
Additional description: Transaminases increased
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Transferrin decreased
|
|
|
Additional description: Transferrin decreased
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
3 |
Visual acuity tests abnormal
|
|
|
Additional description: Visual acuity tests abnormal
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Urine analysis abnormal
|
|
|
Additional description: Urine analysis abnormal
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Weight decreased
|
|
|
Additional description: Weight decreased
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
White blood cell count decreased
|
|
|
Additional description: White blood cell count decreased
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
5 / 127 (3.94%) |
occurrences all number
|
12 |
9 |
White blood cell count increased
|
|
|
Additional description: White blood cell count increased
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
White blood cells urine positive
|
|
|
Additional description: White blood cells urine positive
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Injury, poisoning and procedural complications
|
|
|
Accidental overdose
|
|
|
Additional description: Accidental overdose
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Animal bite
|
|
|
Additional description: Animal bite
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Anaemia postoperative
|
|
|
Additional description: Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Ankle fracture
|
|
|
Additional description: Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Arthropod bite
|
|
|
Additional description: Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Contrast media reaction
|
|
|
Additional description: Contrast media reaction
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Contusion
|
|
|
Additional description: Contusion
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
3 / 127 (2.36%) |
occurrences all number
|
1 |
5 |
Fall
|
|
|
Additional description: Fall
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Foot fracture
|
|
|
Additional description: Foot fracture
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Gastrointestinal disorder postoperative
|
|
|
Additional description: Gastrointestinal disorder postoperative
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Forearm fracture
|
|
|
Additional description: Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Incisional hernia
|
|
|
Additional description: Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Joint dislocation
|
|
|
Additional description: Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Joint injury
|
|
|
Additional description: Joint injury
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Ligament sprain
|
|
|
Additional description: Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Muscle strain
|
|
|
Additional description: Muscle strain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Limb injury
|
|
|
Additional description: Limb injury
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
2 |
2 |
Overdose
|
|
|
Additional description: Overdose
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Postoperative wound complication
|
|
|
Additional description: Postoperative wound complication
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Retinal injury
|
|
|
Additional description: Retinal injury
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Road traffic accident
|
|
|
Additional description: Road traffic accident
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Thermal burn
|
|
|
Additional description: Thermal burn
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Subcutaneous haematoma
|
|
|
Additional description: Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Tibia fracture
|
|
|
Additional description: Tibia fracture
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Traumatic haematoma
|
|
|
Additional description: Traumatic haematoma
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Wound
|
|
|
Additional description: Wound
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Congenital, familial and genetic disorders
|
|
|
Cataract congenital
|
|
|
Additional description: Cataract congenital
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Marfan's syndrome
|
|
|
Additional description: Marfan's syndrome
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac disorders
|
|
|
Angina pectoris
|
|
|
Additional description: Angina pectoris
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Aortic valve calcification
|
|
|
Additional description: Aortic valve calcification
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
3 / 127 (2.36%) |
occurrences all number
|
0 |
3 |
Arrhythmia
|
|
|
Additional description: Arrhythmia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Atrial fibrillation
|
|
|
Additional description: Atrial fibrillation
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
4 / 127 (3.15%) |
occurrences all number
|
4 |
14 |
Atrial flutter
|
|
|
Additional description: Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Atrioventricular block second degree
|
|
|
Additional description: Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Bradycardia
|
|
|
Additional description: Bradycardia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Bundle branch block left
|
|
|
Additional description: Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac failure
|
|
|
Additional description: Cardiac failure
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Cardiac failure chronic
|
|
|
Additional description: Cardiac failure chronic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Cyanosis
|
|
|
Additional description: Cyanosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dilatation ventricular
|
|
|
Additional description: Dilatation ventricular
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Extrasystoles
|
|
|
Additional description: Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Heart valve incompetence
|
|
|
Additional description: Heart valve incompetence
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Hepatojugular reflux
|
|
|
Additional description: Hepatojugular reflux
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Intracardiac thrombus
|
|
|
Additional description: Intracardiac thrombus
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Mitral valve calcification
|
|
|
Additional description: Mitral valve calcification
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Mitral valve incompetence
|
|
|
Additional description: Mitral valve incompetence
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Pericardial cyst
|
|
|
Additional description: Pericardial cyst
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Palpitations
|
|
|
Additional description: Palpitations
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Right atrial enlargement
|
|
|
Additional description: Right atrial enlargement
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Sinoatrial block
|
|
|
Additional description: Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Sinus tachycardia
|
|
|
Additional description: Sinus tachycardia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Supraventricular extrasystoles
|
|
|
Additional description: Supraventricular extrasystoles
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
3 |
Tachycardia
|
|
|
Additional description: Tachycardia
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
2 / 127 (1.57%) |
occurrences all number
|
4 |
3 |
Tricuspid valve incompetence
|
|
|
Additional description: Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Ventricular extrasystoles
|
|
|
Additional description: Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
5 |
Ventricular tachycardia
|
|
|
Additional description: Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Nervous system disorders
|
|
|
Burning sensation
|
|
|
Additional description: Burning sensation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Carotid artery stenosis
|
|
|
Additional description: Carotid artery stenosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Diabetic neuropathy
|
|
|
Additional description: Diabetic neuropathy
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Carpal tunnel syndrome
|
|
|
Additional description: Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dizziness
|
|
|
Additional description: Dizziness
|
|
|
subjects affected / exposed
|
14 / 127 (11.02%) |
11 / 127 (8.66%) |
occurrences all number
|
25 |
16 |
Dysgeusia
|
|
|
Additional description: Dysgeusia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Encephalopathy
|
|
|
Additional description: Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Head discomfort
|
|
|
Additional description: Head discomfort
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Headache
|
|
|
Additional description: Headache
|
|
|
subjects affected / exposed
|
16 / 127 (12.60%) |
18 / 127 (14.17%) |
occurrences all number
|
34 |
28 |
Hypoaesthesia
|
|
|
Additional description: Hypoaesthesia
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
0 / 127 (0.00%) |
occurrences all number
|
6 |
0 |
Intercostal neuralgia
|
|
|
Additional description: Intercostal neuralgia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Loss of consciousness
|
|
|
Additional description: Loss of consciousness
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Lumbar radiculopathy
|
|
|
Additional description: Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Memory impairment
|
|
|
Additional description: Memory impairment
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Migraine
|
|
|
Additional description: Migraine
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Migraine with aura
|
|
|
Additional description: Migraine with aura
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Neuralgia
|
|
|
Additional description: Neuralgia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Neuropathy peripheral
|
|
|
Additional description: Neuropathy peripheral
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Paraesthesia
|
|
|
Additional description: Paraesthesia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
5 / 127 (3.94%) |
occurrences all number
|
0 |
6 |
Parosmia
|
|
|
Additional description: Parosmia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Post herpetic neuralgia
|
|
|
Additional description: Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral nerve lesion
|
|
|
Additional description: Peripheral nerve lesion
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Radiculopathy
|
|
|
Additional description: Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Sciatica
|
|
|
Additional description: Sciatica
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Sinus headache
|
|
|
Additional description: Sinus headache
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Somnolence
|
|
|
Additional description: Somnolence
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Tension headache
|
|
|
Additional description: Tension headache
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Tremor
|
|
|
Additional description: Tremor
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Trigeminal neuritis
|
|
|
Additional description: Trigeminal neuritis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
Additional description: Anaemia
|
|
|
subjects affected / exposed
|
21 / 127 (16.54%) |
37 / 127 (29.13%) |
occurrences all number
|
41 |
67 |
Blood loss anaemia
|
|
|
Additional description: Blood loss anaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cytopenia
|
|
|
Additional description: Cytopenia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Granulocytopenia
|
|
|
Additional description: Granulocytopenia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Iron deficiency anaemia
|
|
|
Additional description: Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
0 / 127 (0.00%) |
occurrences all number
|
9 |
0 |
Leukocytosis
|
|
|
Additional description: Leukocytosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
4 / 127 (3.15%) |
occurrences all number
|
0 |
5 |
Leukopenia
|
|
|
Additional description: Leukopenia
|
|
|
subjects affected / exposed
|
27 / 127 (21.26%) |
31 / 127 (24.41%) |
occurrences all number
|
148 |
82 |
Lymphadenitis
|
|
|
Additional description: Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Lymphadenopathy
|
|
|
Additional description: Lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
3 / 127 (2.36%) |
occurrences all number
|
0 |
3 |
Microcytic anaemia
|
|
|
Additional description: Microcytic anaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Neutropenia
|
|
|
Additional description: Neutropenia
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
7 / 127 (5.51%) |
occurrences all number
|
7 |
14 |
Pancytopenia
|
|
|
Additional description: Pancytopenia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Polycythaemia
|
|
|
Additional description: Polycythaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Splenic cyst
|
|
|
Additional description: Splenic cyst
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Splenic infarction
|
|
|
Additional description: Splenic infarction
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Splenomegaly
|
|
|
Additional description: Splenomegaly
|
|
|
subjects affected / exposed
|
13 / 127 (10.24%) |
8 / 127 (6.30%) |
occurrences all number
|
13 |
8 |
Thrombocytopenia
|
|
|
Additional description: Thrombocytopenia
|
|
|
subjects affected / exposed
|
28 / 127 (22.05%) |
37 / 127 (29.13%) |
occurrences all number
|
81 |
101 |
Thrombocytosis
|
|
|
Additional description: Thrombocytosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
3 / 127 (2.36%) |
occurrences all number
|
2 |
4 |
Ear and labyrinth disorders
|
|
|
Cerumen impaction
|
|
|
Additional description: Cerumen impaction
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Deafness neurosensory
|
|
|
Additional description: Deafness neurosensory
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Ear discomfort
|
|
|
Additional description: Ear discomfort
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Tinnitus
|
|
|
Additional description: Tinnitus
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
8 |
1 |
Vertigo
|
|
|
Additional description: Vertigo
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
8 / 127 (6.30%) |
occurrences all number
|
5 |
9 |
Vestibular disorder
|
|
|
Additional description: Vestibular disorder
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
Age-related macular degeneration
|
|
|
Additional description: Age-related macular degeneration
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Asthenopia
|
|
|
Additional description: Asthenopia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Blepharitis
|
|
|
Additional description: Blepharitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Blepharochalasis
|
|
|
Additional description: Blepharochalasis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Cataract
|
|
|
Additional description: Cataract
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
3 / 127 (2.36%) |
occurrences all number
|
8 |
4 |
Chalazion
|
|
|
Additional description: Chalazion
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Conjunctival haemorrhage
|
|
|
Additional description: Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Corneal opacity
|
|
|
Additional description: Corneal opacity
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Diabetic retinopathy
|
|
|
Additional description: Diabetic retinopathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dry eye
|
|
|
Additional description: Dry eye
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
3 / 127 (2.36%) |
occurrences all number
|
7 |
3 |
Ectropion
|
|
|
Additional description: Ectropion
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eye haemorrhage
|
|
|
Additional description: Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eye inflammation
|
|
|
Additional description: Eye inflammation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eye irritation
|
|
|
Additional description: Eye irritation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Eye pain
|
|
|
Additional description: Eye pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eye pruritus
|
|
|
Additional description: Eye pruritus
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eyelid ptosis
|
|
|
Additional description: Eyelid ptosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Eyelid skin dryness
|
|
|
Additional description: Eyelid skin dryness
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Iridocyclitis
|
|
|
Additional description: Iridocyclitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Keratopathy
|
|
|
Additional description: Keratopathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Maculopathy
|
|
|
Additional description: Maculopathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Myopia
|
|
|
Additional description: Myopia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Posterior capsule opacification
|
|
|
Additional description: Posterior capsule opacification
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Presbyopia
|
|
|
Additional description: Presbyopia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Retinopathy
|
|
|
Additional description: Retinopathy
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Retinopathy hypertensive
|
|
|
Additional description: Retinopathy hypertensive
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Vision blurred
|
|
|
Additional description: Vision blurred
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Visual acuity reduced
|
|
|
Additional description: Visual acuity reduced
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Vitreous haemorrhage
|
|
|
Additional description: Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
Additional description: Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Abdominal distension
|
|
|
Additional description: Abdominal distension
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
2 |
Abdominal pain
|
|
|
Additional description: Abdominal pain
|
|
|
subjects affected / exposed
|
8 / 127 (6.30%) |
7 / 127 (5.51%) |
occurrences all number
|
10 |
14 |
Abdominal pain upper
|
|
|
Additional description: Abdominal pain upper
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
7 / 127 (5.51%) |
occurrences all number
|
6 |
12 |
Abdominal wall disorder
|
|
|
Additional description: Abdominal wall disorder
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Aphthous ulcer
|
|
|
Additional description: Aphthous ulcer
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Bowel movement irregularity
|
|
|
Additional description: Bowel movement irregularity
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Burning mouth syndrome
|
|
|
Additional description: Burning mouth syndrome
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Chronic gastritis
|
|
|
Additional description: Chronic gastritis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
3 |
Colitis
|
|
|
Additional description: Colitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Constipation
|
|
|
Additional description: Constipation
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
6 / 127 (4.72%) |
occurrences all number
|
6 |
6 |
Dental caries
|
|
|
Additional description: Dental caries
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Diarrhoea
|
|
|
Additional description: Diarrhoea
|
|
|
subjects affected / exposed
|
11 / 127 (8.66%) |
15 / 127 (11.81%) |
occurrences all number
|
28 |
29 |
Diverticulum intestinal
|
|
|
Additional description: Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dry mouth
|
|
|
Additional description: Dry mouth
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Duodenogastric reflux
|
|
|
Additional description: Duodenogastric reflux
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Dyspepsia
|
|
|
Additional description: Dyspepsia
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
2 / 127 (1.57%) |
occurrences all number
|
6 |
6 |
Dysphagia
|
|
|
Additional description: Dysphagia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Epigastric discomfort
|
|
|
Additional description: Epigastric discomfort
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Flatulence
|
|
|
Additional description: Flatulence
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gastric disorder
|
|
|
Additional description: Gastric disorder
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
2 |
Gastritis
|
|
|
Additional description: Gastritis
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
3 |
Gastritis erosive
|
|
|
Additional description: Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal angiodysplasia
|
|
|
Additional description: Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal disorder
|
|
|
Additional description: Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal motility disorder
|
|
|
Additional description: Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Gastrointestinal pain
|
|
|
Additional description: Gastrointestinal pain
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gastrointestinal scarring
|
|
|
Additional description: Gastrointestinal scarring
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrooesophageal reflux disease
|
|
|
Additional description: Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
1 / 127 (0.79%) |
occurrences all number
|
5 |
1 |
Gastrooesophageal sphincter insufficiency
|
|
|
Additional description: Gastrooesophageal sphincter insufficiency
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gingival bleeding
|
|
|
Additional description: Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Gingival hypertrophy
|
|
|
Additional description: Gingival hypertrophy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gingival pain
|
|
|
Additional description: Gingival pain
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gingival recession
|
|
|
Additional description: Gingival recession
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gingivitis ulcerative
|
|
|
Additional description: Gingivitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Haematemesis
|
|
|
Additional description: Haematemesis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Haematochezia
|
|
|
Additional description: Haematochezia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Haemorrhoidal haemorrhage
|
|
|
Additional description: Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Haemorrhoids
|
|
|
Additional description: Haemorrhoids
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Inguinal hernia
|
|
|
Additional description: Inguinal hernia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Intra-abdominal haematoma
|
|
|
Additional description: Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Irritable bowel syndrome
|
|
|
Additional description: Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Mouth swelling
|
|
|
Additional description: Mouth swelling
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Nausea
|
|
|
Additional description: Nausea
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
17 / 127 (13.39%) |
occurrences all number
|
6 |
21 |
Oesophagitis
|
|
|
Additional description: Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Pancreatitis
|
|
|
Additional description: Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Pancreatitis chronic
|
|
|
Additional description: Pancreatitis chronic
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |
Paraesthesia oral
|
|
|
Additional description: Paraesthesia oral
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Rectal fissure
|
|
|
Additional description: Rectal fissure
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Rectal haemorrhage
|
|
|
Additional description: Rectal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Rectal polyp
|
|
|
Additional description: Rectal polyp
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Reflux gastritis
|
|
|
Additional description: Reflux gastritis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Stomatitis
|
|
|
Additional description: Stomatitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
2 |
5 |
Toothache
|
|
|
Additional description: Toothache
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Truncus coeliacus thrombosis
|
|
|
Additional description: Truncus coeliacus thrombosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Vomiting
|
|
|
Additional description: Vomiting
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
6 / 127 (4.72%) |
occurrences all number
|
3 |
7 |
Skin and subcutaneous tissue disorders
|
|
|
Acanthosis nigricans
|
|
|
Additional description: Acanthosis nigricans
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Actinic keratosis
|
|
|
Additional description: Actinic keratosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Alopecia
|
|
|
Additional description: Alopecia
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
0 / 127 (0.00%) |
occurrences all number
|
9 |
0 |
Blood blister
|
|
|
Additional description: Blood blister
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dermal cyst
|
|
|
Additional description: Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dermatitis
|
|
|
Additional description: Dermatitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Dermatitis acneiform
|
|
|
Additional description: Dermatitis acneiform
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dry skin
|
|
|
Additional description: Dry skin
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
5 / 127 (3.94%) |
occurrences all number
|
2 |
5 |
Eczema
|
|
|
Additional description: Eczema
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
6 |
1 |
Erythema
|
|
|
Additional description: Erythema
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
1 / 127 (0.79%) |
occurrences all number
|
7 |
1 |
Erythrosis
|
|
|
Additional description: Erythrosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Haemorrhage subcutaneous
|
|
|
Additional description: Haemorrhage subcutaneous
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Henoch-Schonlein purpura
|
|
|
Additional description: Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hyperhidrosis
|
|
|
Additional description: Hyperhidrosis
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Hyperkeratosis
|
|
|
Additional description: Hyperkeratosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Night sweats
|
|
|
Additional description: Night sweats
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
4 / 127 (3.15%) |
occurrences all number
|
2 |
4 |
Photosensitivity reaction
|
|
|
Additional description: Photosensitivity reaction
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Pruritus
|
|
|
Additional description: Pruritus
|
|
|
subjects affected / exposed
|
10 / 127 (7.87%) |
9 / 127 (7.09%) |
occurrences all number
|
75 |
11 |
Pruritus generalised
|
|
|
Additional description: Pruritus generalised
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Psoriasis
|
|
|
Additional description: Psoriasis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Rash
|
|
|
Additional description: Rash
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
5 / 127 (3.94%) |
occurrences all number
|
3 |
7 |
Rash erythematous
|
|
|
Additional description: Rash erythematous
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Rash papular
|
|
|
Additional description: Rash papular
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Rosacea
|
|
|
Additional description: Rosacea
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Skin disorder
|
|
|
Additional description: Skin disorder
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Skin exfoliation
|
|
|
Additional description: Skin exfoliation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Skin fissures
|
|
|
Additional description: Skin fissures
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Skin hyperpigmentation
|
|
|
Additional description: Skin hyperpigmentation
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Skin swelling
|
|
|
Additional description: Skin swelling
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Skin ulcer
|
|
|
Additional description: Skin ulcer
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
7 / 127 (5.51%) |
occurrences all number
|
0 |
9 |
Urticaria
|
|
|
Additional description: Urticaria
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Xeroderma
|
|
|
Additional description: Xeroderma
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Renal and urinary disorders
|
|
|
Calculus urinary
|
|
|
Additional description: Calculus urinary
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
7 |
1 |
Chronic kidney disease
|
|
|
Additional description: Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Diabetic nephropathy
|
|
|
Additional description: Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Dysuria
|
|
|
Additional description: Dysuria
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
3 / 127 (2.36%) |
occurrences all number
|
2 |
3 |
Haematuria
|
|
|
Additional description: Haematuria
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
3 / 127 (2.36%) |
occurrences all number
|
2 |
3 |
Leukocyturia
|
|
|
Additional description: Leukocyturia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
3 / 127 (2.36%) |
occurrences all number
|
2 |
3 |
Micturition urgency
|
|
|
Additional description: Micturition urgency
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Nephrolithiasis
|
|
|
Additional description: Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Nephropathy
|
|
|
Additional description: Nephropathy
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Nephropathy toxic
|
|
|
Additional description: Nephropathy toxic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Nephroptosis
|
|
|
Additional description: Nephroptosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Nocturia
|
|
|
Additional description: Nocturia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Proteinuria
|
|
|
Additional description: Proteinuria
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
3 |
Pyelocaliectasis
|
|
|
Additional description: Pyelocaliectasis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Renal cyst
|
|
|
Additional description: Renal cyst
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
7 / 127 (5.51%) |
occurrences all number
|
2 |
7 |
Renal colic
|
|
|
Additional description: Renal colic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Tubulointerstitial nephritis
|
|
|
Additional description: Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Urinary incontinence
|
|
|
Additional description: Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary retention
|
|
|
Additional description: Urinary retention
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary tract disorder
|
|
|
Additional description: Urinary tract disorder
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Endocrine disorders
|
|
|
Autoimmune thyroiditis
|
|
|
Additional description: Autoimmune thyroiditis
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
1 |
Goitre
|
|
|
Additional description: Goitre
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Hyperthyroidism
|
|
|
Additional description: Hyperthyroidism
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
0 / 127 (0.00%) |
occurrences all number
|
4 |
0 |
Hypothyroidism
|
|
|
Additional description: Hypothyroidism
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
2 / 127 (1.57%) |
occurrences all number
|
7 |
2 |
Thyroiditis
|
|
|
Additional description: Thyroiditis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
Additional description: Arthralgia
|
|
|
subjects affected / exposed
|
18 / 127 (14.17%) |
6 / 127 (4.72%) |
occurrences all number
|
39 |
10 |
Arthritis
|
|
|
Additional description: Arthritis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Arthritis reactive
|
|
|
Additional description: Arthritis reactive
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Back pain
|
|
|
Additional description: Back pain
|
|
|
subjects affected / exposed
|
13 / 127 (10.24%) |
7 / 127 (5.51%) |
occurrences all number
|
18 |
10 |
Bone pain
|
|
|
Additional description: Bone pain
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
3 / 127 (2.36%) |
occurrences all number
|
3 |
3 |
Bursitis
|
|
|
Additional description: Bursitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Diffuse idiopathic skeletal hyperostosis
|
|
|
Additional description: Diffuse idiopathic skeletal hyperostosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gouty arthritis
|
|
|
Additional description: Gouty arthritis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Groin pain
|
|
|
Additional description: Groin pain
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Haemarthrosis
|
|
|
Additional description: Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Intervertebral disc protrusion
|
|
|
Additional description: Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Joint swelling
|
|
|
Additional description: Joint swelling
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
3 |
Muscle spasms
|
|
|
Additional description: Muscle spasms
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
3 / 127 (2.36%) |
occurrences all number
|
4 |
3 |
Muscular weakness
|
|
|
Additional description: Muscular weakness
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
0 / 127 (0.00%) |
occurrences all number
|
5 |
0 |
Musculoskeletal chest pain
|
|
|
Additional description: Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
8 |
1 |
Musculoskeletal pain
|
|
|
Additional description: Musculoskeletal pain
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
0 / 127 (0.00%) |
occurrences all number
|
14 |
0 |
Musculoskeletal stiffness
|
|
|
Additional description: Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Myalgia
|
|
|
Additional description: Myalgia
|
|
|
subjects affected / exposed
|
12 / 127 (9.45%) |
6 / 127 (4.72%) |
occurrences all number
|
20 |
11 |
Neck pain
|
|
|
Additional description: Neck pain
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Osteoarthritis
|
|
|
Additional description: Osteoarthritis
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
2 / 127 (1.57%) |
occurrences all number
|
8 |
3 |
Osteochondrosis
|
|
|
Additional description: Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Osteopenia
|
|
|
Additional description: Osteopenia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Osteoporosis
|
|
|
Additional description: Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Pain in extremity
|
|
|
Additional description: Pain in extremity
|
|
|
subjects affected / exposed
|
10 / 127 (7.87%) |
6 / 127 (4.72%) |
occurrences all number
|
16 |
6 |
Rotator cuff syndrome
|
|
|
Additional description: Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Scoliosis
|
|
|
Additional description: Scoliosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Sjogren's syndrome
|
|
|
Additional description: Sjogren's syndrome
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Spinal osteoarthritis
|
|
|
Additional description: Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Spinal retrolisthesis
|
|
|
Additional description: Spinal retrolisthesis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal pain
|
|
|
Additional description: Spinal pain
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
5 / 127 (3.94%) |
occurrences all number
|
4 |
5 |
Spondylolisthesis
|
|
|
Additional description: Spondylolisthesis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Temporomandibular joint syndrome
|
|
|
Additional description: Temporomandibular joint syndrome
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Tendonitis
|
|
|
Additional description: Tendonitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Infections and infestations
|
|
|
Alveolar osteitis
|
|
|
Additional description: Alveolar osteitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Acute sinusitis
|
|
|
Additional description: Acute sinusitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
2 |
Borrelia infection
|
|
|
Additional description: Borrelia infection
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Bronchitis
|
|
|
Additional description: Bronchitis
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
12 / 127 (9.45%) |
occurrences all number
|
10 |
13 |
COVID-19
|
|
|
Additional description: COVID-19
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
3 / 127 (2.36%) |
occurrences all number
|
3 |
3 |
COVID-19 pneumonia
|
|
|
Additional description: COVID-19 pneumonia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Conjunctivitis
|
|
|
Additional description: Conjunctivitis
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
2 |
Chronic sinusitis
|
|
|
Additional description: Chronic sinusitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Cystitis
|
|
|
Additional description: Cystitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
3 / 127 (2.36%) |
occurrences all number
|
7 |
6 |
Ear infection
|
|
|
Additional description: Ear infection
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Erysipelas
|
|
|
Additional description: Erysipelas
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Folliculitis
|
|
|
Additional description: Folliculitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
2 |
Fungal infection
|
|
|
Additional description: Fungal infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Fungal skin infection
|
|
|
Additional description: Fungal skin infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Furuncle
|
|
|
Additional description: Furuncle
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Gastroenteritis
|
|
|
Additional description: Gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Gastrointestinal viral infection
|
|
|
Additional description: Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Herpes zoster
|
|
|
Additional description: Herpes zoster
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
2 / 127 (1.57%) |
occurrences all number
|
5 |
2 |
Hordeolum
|
|
|
Additional description: Hordeolum
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Infected dermal cyst
|
|
|
Additional description: Infected dermal cyst
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Infection
|
|
|
Additional description: Infection
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Influenza
|
|
|
Additional description: Influenza
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
15 / 127 (11.81%) |
occurrences all number
|
7 |
15 |
Laryngitis
|
|
|
Additional description: Laryngitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Lower respiratory tract infection
|
|
|
Additional description: Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Lyme disease
|
|
|
Additional description: Lyme disease
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Nasopharyngitis
|
|
|
Additional description: Nasopharyngitis
|
|
|
subjects affected / exposed
|
9 / 127 (7.09%) |
14 / 127 (11.02%) |
occurrences all number
|
20 |
24 |
Oesophageal candidiasis
|
|
|
Additional description: Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Onychomycosis
|
|
|
Additional description: Onychomycosis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Oral candidiasis
|
|
|
Additional description: Oral candidiasis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Oral fungal infection
|
|
|
Additional description: Oral fungal infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Oral herpes
|
|
|
Additional description: Oral herpes
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
3 / 127 (2.36%) |
occurrences all number
|
5 |
4 |
Oral infection
|
|
|
Additional description: Oral infection
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Otitis externa
|
|
|
Additional description: Otitis externa
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Parainfluenzae virus infection
|
|
|
Additional description: Parainfluenzae virus infection
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Paronychia
|
|
|
Additional description: Paronychia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Periodontitis
|
|
|
Additional description: Periodontitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Pharyngitis
|
|
|
Additional description: Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
3 / 127 (2.36%) |
occurrences all number
|
1 |
7 |
Pharyngotonsillitis
|
|
|
Additional description: Pharyngotonsillitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Pneumonia
|
|
|
Additional description: Pneumonia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
4 |
Pulpitis dental
|
|
|
Additional description: Pulpitis dental
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Pyelonephritis acute
|
|
|
Additional description: Pyelonephritis acute
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Pyelonephritis chronic
|
|
|
Additional description: Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory tract infection
|
|
|
Additional description: Respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
4 / 127 (3.15%) |
occurrences all number
|
4 |
4 |
Respiratory tract infection viral
|
|
|
Additional description: Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Rhinitis
|
|
|
Additional description: Rhinitis
|
|
|
subjects affected / exposed
|
7 / 127 (5.51%) |
3 / 127 (2.36%) |
occurrences all number
|
9 |
4 |
Rhinotracheitis
|
|
|
Additional description: Rhinotracheitis
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Sinusitis
|
|
|
Additional description: Sinusitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
4 / 127 (3.15%) |
occurrences all number
|
2 |
5 |
Staphylococcal infection
|
|
|
Additional description: Staphylococcal infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Tinea versicolour
|
|
|
Additional description: Tinea versicolour
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Tonsillitis
|
|
|
Additional description: Tonsillitis
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Tooth infection
|
|
|
Additional description: Tooth infection
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Tracheitis
|
|
|
Additional description: Tracheitis
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Urinary tract infection
|
|
|
Additional description: Urinary tract infection
|
|
|
subjects affected / exposed
|
8 / 127 (6.30%) |
8 / 127 (6.30%) |
occurrences all number
|
17 |
11 |
Upper respiratory tract infection
|
|
|
Additional description: Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
11 / 127 (8.66%) |
7 / 127 (5.51%) |
occurrences all number
|
18 |
12 |
Viraemia
|
|
|
Additional description: Viraemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Viral infection
|
|
|
Additional description: Viral infection
|
|
|
subjects affected / exposed
|
6 / 127 (4.72%) |
0 / 127 (0.00%) |
occurrences all number
|
6 |
0 |
Vulvovaginal mycotic infection
|
|
|
Additional description: Vulvovaginal mycotic infection
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
2 / 127 (1.57%) |
occurrences all number
|
0 |
2 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
Additional description: Decreased appetite
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
2 / 127 (1.57%) |
occurrences all number
|
3 |
3 |
Dehydration
|
|
|
Additional description: Dehydration
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Diabetes mellitus
|
|
|
Additional description: Diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Diabetic metabolic decompensation
|
|
|
Additional description: Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Dyslipidaemia
|
|
|
Additional description: Dyslipidaemia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
2 |
1 |
Folate deficiency
|
|
|
Additional description: Folate deficiency
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Gout
|
|
|
Additional description: Gout
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercalcaemia
|
|
|
Additional description: Hypercalcaemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hyperchloraemia
|
|
|
Additional description: Hyperchloraemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
0 / 127 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercholesterolaemia
|
|
|
Additional description: Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
3 |
Hyperglycaemia
|
|
|
Additional description: Hyperglycaemia
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
1 / 127 (0.79%) |
occurrences all number
|
6 |
1 |
Hyperkalaemia
|
|
|
Additional description: Hyperkalaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
3 / 127 (2.36%) |
occurrences all number
|
2 |
5 |
Hyperlipidaemia
|
|
|
Additional description: Hyperlipidaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
2 / 127 (1.57%) |
occurrences all number
|
1 |
2 |
Hypernatraemia
|
|
|
Additional description: Hypernatraemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hypertriglyceridaemia
|
|
|
Additional description: Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
4 / 127 (3.15%) |
occurrences all number
|
1 |
4 |
Hyperuricaemia
|
|
|
Additional description: Hyperuricaemia
|
|
|
subjects affected / exposed
|
4 / 127 (3.15%) |
3 / 127 (2.36%) |
occurrences all number
|
6 |
4 |
Hypoalbuminaemia
|
|
|
Additional description: Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
0 / 127 (0.00%) |
occurrences all number
|
3 |
0 |
Hypocalcaemia
|
|
|
Additional description: Hypocalcaemia
|
|
|
subjects affected / exposed
|
5 / 127 (3.94%) |
2 / 127 (1.57%) |
occurrences all number
|
10 |
6 |
Hypoglycaemia
|
|
|
Additional description: Hypoglycaemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hypokalaemia
|
|
|
Additional description: Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
1 / 127 (0.79%) |
occurrences all number
|
4 |
2 |
Hypomagnesaemia
|
|
|
Additional description: Hypomagnesaemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Hyponatraemia
|
|
|
Additional description: Hyponatraemia
|
|
|
subjects affected / exposed
|
2 / 127 (1.57%) |
0 / 127 (0.00%) |
occurrences all number
|
2 |
0 |
Hypoproteinaemia
|
|
|
Additional description: Hypoproteinaemia
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Iron deficiency
|
|
|
Additional description: Iron deficiency
|
|
|
subjects affected / exposed
|
8 / 127 (6.30%) |
4 / 127 (3.15%) |
occurrences all number
|
14 |
10 |
Magnesium deficiency
|
|
|
Additional description: Magnesium deficiency
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Steroid diabetes
|
|
|
Additional description: Steroid diabetes
|
|
|
subjects affected / exposed
|
0 / 127 (0.00%) |
1 / 127 (0.79%) |
occurrences all number
|
0 |
1 |
Type 2 diabetes mellitus
|
|
|
Additional description: Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 127 (0.79%) |
1 / 127 (0.79%) |
occurrences all number
|
1 |
1 |
Vitamin D deficiency
|
|
|
Additional description: Vitamin D deficiency
|
|
|
subjects affected / exposed
|
3 / 127 (2.36%) |
1 / 127 (0.79%) |
occurrences all number
|
3 |
1 |