Non-serious adverse events
|
Inclisiran-only |
Switching |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
280 / 284 (98.59%) |
85 / 87 (97.70%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
13 / 284 (4.58%) |
3 / 87 (3.45%) |
occurrences all number
|
13 |
3 |
Benign neoplasm of eyelid
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Blepharal papilloma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Fibroma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Haemangioma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Haemangioma of liver
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hypergammaglobulinaemia benign monoclonal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Intraductal papillary mucinous neoplasm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lipoma
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Melanocytic naevus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Meningioma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Oesophageal papilloma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Oral papilloma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Ovarian fibroma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Papilloma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Phaeochromocytoma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Prostatic adenoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Skin papilloma
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Aortic dilatation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Flushing
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Haematoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Hot flush
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Hypertension
|
|
|
subjects affected / exposed
|
49 / 284 (17.25%) |
19 / 87 (21.84%) |
occurrences all number
|
47 |
20 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
2 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hypotension
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
1 / 87 (1.15%) |
occurrences all number
|
6 |
1 |
Iliac artery stenosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
1 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Peripheral coldness
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Post thrombotic syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Varicophlebitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Varicose vein
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Surgical and medical procedures
|
|
|
Abortion induced
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Application site erythema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Asthenia
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
5 |
0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
1 / 87 (1.15%) |
occurrences all number
|
5 |
1 |
Chest pain
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
4 / 87 (4.60%) |
occurrences all number
|
6 |
2 |
Chills
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Complication of device insertion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Crepitations
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cyst
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Discomfort
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Drug intolerance
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Face oedema
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Fatigue
|
|
|
subjects affected / exposed
|
29 / 284 (10.21%) |
18 / 87 (20.69%) |
occurrences all number
|
26 |
14 |
Feeling abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gravitational oedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Hernia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Hunger
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
20 / 284 (7.04%) |
5 / 87 (5.75%) |
occurrences all number
|
19 |
3 |
Injection site bruising
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
6 / 87 (6.90%) |
occurrences all number
|
5 |
9 |
Injection site discolouration
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Injection site discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Injection site erythema
|
|
|
subjects affected / exposed
|
15 / 284 (5.28%) |
3 / 87 (3.45%) |
occurrences all number
|
21 |
4 |
Injection site haematoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Injection site haemorrhage
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Injection site induration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Injection site oedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Injection site pain
|
|
|
subjects affected / exposed
|
15 / 284 (5.28%) |
4 / 87 (4.60%) |
occurrences all number
|
23 |
4 |
Injection site paraesthesia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Injection site pruritus
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Injection site rash
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
1 / 87 (1.15%) |
occurrences all number
|
14 |
1 |
Injection site reaction
|
|
|
subjects affected / exposed
|
18 / 284 (6.34%) |
5 / 87 (5.75%) |
occurrences all number
|
33 |
7 |
Injection site urticaria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Injection site vesicles
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Injection site warmth
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Malaise
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Medical device complication
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nodule
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
19 / 284 (6.69%) |
7 / 87 (8.05%) |
occurrences all number
|
17 |
5 |
Oedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
17 / 284 (5.99%) |
9 / 87 (10.34%) |
occurrences all number
|
11 |
8 |
Pain
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
5 / 87 (5.75%) |
occurrences all number
|
4 |
2 |
Polyp
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pyrexia
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
1 |
Sensation of foreign body
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Suprapubic pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Swelling
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Swelling face
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Vessel puncture site bruise
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vessel puncture site induration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vessel puncture site pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Immune system disorders
|
|
|
Allergy to animal
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Allergy to arthropod bite
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Allergy to arthropod sting
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Food allergy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
2 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Mite allergy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Seasonal allergy
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
5 / 87 (5.75%) |
occurrences all number
|
4 |
4 |
Reproductive system and breast disorders
|
|
|
Atrophic vulvovaginitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Balanoposthitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
3 / 87 (3.45%) |
occurrences all number
|
8 |
4 |
Breast disorder female
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Breast pain
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
4 |
0 |
Breast tenderness
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cervix disorder
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Dysmenorrhoea
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Erectile dysfunction
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Genital rash
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gynaecomastia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Haematospermia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Heavy menstrual bleeding
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Menopausal symptoms
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nipple pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Penile erythema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
2 |
Prostatitis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Pruritus genital
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Rectocele
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Scrotal pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Spermatocele
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Testicular swelling
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Vaginal dysplasia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Vulvovaginal discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Vulvovaginal pain
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Vulvovaginal pruritus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Asthma
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
4 / 87 (4.60%) |
occurrences all number
|
13 |
5 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
2 / 87 (2.30%) |
occurrences all number
|
11 |
3 |
Cough
|
|
|
subjects affected / exposed
|
37 / 284 (13.03%) |
12 / 87 (13.79%) |
occurrences all number
|
25 |
6 |
Dry throat
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Dysphonia
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
2 |
Dyspnoea
|
|
|
subjects affected / exposed
|
26 / 284 (9.15%) |
11 / 87 (12.64%) |
occurrences all number
|
22 |
8 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
5 / 87 (5.75%) |
occurrences all number
|
10 |
5 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Epistaxis
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
4 / 87 (4.60%) |
occurrences all number
|
11 |
1 |
Hiccups
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hypoxia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal congestion
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Nasal obstruction
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal septum deviation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Oropharyngeal discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
15 / 284 (5.28%) |
3 / 87 (3.45%) |
occurrences all number
|
8 |
2 |
Oropharyngeal spasm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Pneumothorax
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Productive cough
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Pulmonary calcification
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Reflux laryngitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
4 |
Respiratory tract congestion
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Rhinorrhoea
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Sinonasal obstruction
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Sinus congestion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
3 / 87 (3.45%) |
occurrences all number
|
1 |
2 |
Sinus disorder
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Sinus polyp
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Sneezing
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Snoring
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Throat irritation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tonsillar hypertrophy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Upper respiratory tract irritation
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Upper-airway cough syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Wheezing
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Psychiatric disorders
|
|
|
Acute stress disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Adjustment disorder with depressed mood
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Aggression
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Agitation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Alcoholism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Anxiety
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
2 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Bruxism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Burnout syndrome
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Confusional state
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Depressed mood
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Depression
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
2 / 87 (2.30%) |
occurrences all number
|
12 |
0 |
Disorientation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Emotional disorder
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Emotional distress
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Fear
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Indifference
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Insomnia
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
8 / 87 (9.20%) |
occurrences all number
|
10 |
2 |
Intentional self-injury
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Middle insomnia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Mood altered
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Nightmare
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Panic attack
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Poor quality sleep
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Seasonal affective disorder
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Stress
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Prosthetic cardiac valve failure
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hepatobiliary disorders
|
|
|
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
0 / 87 (0.00%) |
occurrences all number
|
7 |
0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Hepatic cyst
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Hepatic fibrosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
2 / 87 (2.30%) |
occurrences all number
|
6 |
2 |
Investigations
|
|
|
Activated partial thromboplastin time prolonged
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
2 / 87 (2.30%) |
occurrences all number
|
4 |
2 |
Antineutrophil cytoplasmic antibody increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Bilirubin conjugated increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
2 / 87 (2.30%) |
occurrences all number
|
4 |
0 |
Blood calcium increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blood creatine phosphokinase increased
|
|
|
subjects affected / exposed
|
12 / 284 (4.23%) |
7 / 87 (8.05%) |
occurrences all number
|
10 |
2 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Blood folate decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blood glucose abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blood glucose fluctuation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
3 / 87 (3.45%) |
occurrences all number
|
5 |
2 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Blood potassium increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
3 / 87 (3.45%) |
occurrences all number
|
1 |
2 |
Blood sodium decreased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blood testosterone decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Blood uric acid decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blood uric acid increased
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Blood urine present
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
0 / 87 (0.00%) |
occurrences all number
|
5 |
0 |
Body temperature increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Carbohydrate antigen 19-9 increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Carcinoembryonic antigen increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Cardiac murmur
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Carotid bruit
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Electrocardiogram T wave abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Eosinophil count increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Gamma-glutamyltransferase abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Glucose urine present
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Haematocrit decreased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Heart rate decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
2 / 87 (2.30%) |
occurrences all number
|
9 |
2 |
Hormone level abnormal
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
International normalised ratio decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Intraocular pressure increased
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Lipoprotein (a) increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lipoprotein increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Low density lipoprotein increased
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Lymphocyte count decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Mean cell haemoglobin concentration decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Mean cell haemoglobin increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Mean cell volume increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Neutrophil count increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Platelet count increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Prostatic specific antigen increased
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Pulmonary function test decreased
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Pulse absent
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
QRS axis abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
SARS-CoV-2 test positive
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Sinus rhythm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Spirometry abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Streptococcus test positive
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Thyroid function test abnormal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Troponin T increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Urine analysis abnormal
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Vitamin B12 decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vitamin D decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Weight decreased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
3 / 87 (3.45%) |
occurrences all number
|
1 |
2 |
Weight increased
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
White blood cell count decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Injury, poisoning and procedural complications
|
|
|
Accident
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Accidental use of placebo
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Animal bite
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Arthropod bite
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
1 / 87 (1.15%) |
occurrences all number
|
5 |
0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Back injury
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Bone contusion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Burns second degree
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Chest injury
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Concussion
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
3 / 87 (3.45%) |
occurrences all number
|
2 |
3 |
Contusion
|
|
|
subjects affected / exposed
|
20 / 284 (7.04%) |
10 / 87 (11.49%) |
occurrences all number
|
18 |
8 |
Corneal abrasion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Epicondylitis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
5 |
1 |
Eye contusion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Eye injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Fall
|
|
|
subjects affected / exposed
|
29 / 284 (10.21%) |
4 / 87 (4.60%) |
occurrences all number
|
34 |
4 |
Fibula fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Foot fracture
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
2 / 87 (2.30%) |
occurrences all number
|
4 |
1 |
Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Foreign body
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hand fracture
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Head injury
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
4 |
0 |
Hip fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Hypobarism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Incorrect dose administered
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Inflammation of wound
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Injection related reaction
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Joint injury
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Ligament rupture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Ligament sprain
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
3 / 87 (3.45%) |
occurrences all number
|
6 |
0 |
Limb injury
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
4 / 87 (4.60%) |
occurrences all number
|
2 |
4 |
Lip injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Medication error
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Muscle rupture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Muscle strain
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
0 / 87 (0.00%) |
occurrences all number
|
7 |
0 |
Musculoskeletal injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Patella fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Periorbital haematoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Post procedural discomfort
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Post procedural oedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Post procedural swelling
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Post-traumatic neck syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Post-traumatic pain
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Procedural nausea
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Procedural pain
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
2 |
Product dispensing error
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Reactive gastropathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Rib fracture
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Road traffic accident
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
3 |
Skin abrasion
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
2 / 87 (2.30%) |
occurrences all number
|
6 |
1 |
Skin laceration
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
5 / 87 (5.75%) |
occurrences all number
|
2 |
3 |
Sunburn
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Tendon injury
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Thermal burn
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Tibia fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tooth fracture
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
0 / 87 (0.00%) |
occurrences all number
|
5 |
0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Traumatic liver injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Traumatic shock
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Ulnar nerve injury
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vaccination complication
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
0 / 87 (0.00%) |
occurrences all number
|
7 |
0 |
Wound
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Wrong dose
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Congenital, familial and genetic disorders
|
|
|
Corneal dystrophy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hydrocele
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Phimosis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Cardiac disorders
|
|
|
Angina pectoris
|
|
|
subjects affected / exposed
|
24 / 284 (8.45%) |
12 / 87 (13.79%) |
occurrences all number
|
20 |
10 |
Angina unstable
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
16 / 284 (5.63%) |
3 / 87 (3.45%) |
occurrences all number
|
14 |
2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
2 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
1 |
Bradycardia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Bundle branch block right
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Cardiac failure
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
2 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Coronary artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
5 |
2 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Dilatation atrial
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Mitral valve prolapse
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Palpitations
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
3 / 87 (3.45%) |
occurrences all number
|
8 |
2 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Right ventricular dilatation
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tachycardia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Trifascicular block
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Ventricular hypokinesia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
3 |
Nervous system disorders
|
|
|
Ageusia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Amnesia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Anosmia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Balance disorder
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Burning sensation
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Carotid arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
3 / 87 (3.45%) |
occurrences all number
|
0 |
2 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
1 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
3 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Clonus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Cluster headache
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Cubital tunnel syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Disturbance in attention
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Dizziness
|
|
|
subjects affected / exposed
|
36 / 284 (12.68%) |
16 / 87 (18.39%) |
occurrences all number
|
27 |
11 |
Dizziness postural
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Dysarthria
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Dysgeusia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Epilepsy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Head discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Headache
|
|
|
subjects affected / exposed
|
34 / 284 (11.97%) |
14 / 87 (16.09%) |
occurrences all number
|
26 |
18 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Hyperaesthesia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
5 / 87 (5.75%) |
occurrences all number
|
4 |
3 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lumbosacral radiculopathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Memory impairment
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Migraine
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
4 / 87 (4.60%) |
occurrences all number
|
2 |
4 |
Migraine with aura
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Muscle tension dysphonia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Nerve compression
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Occipital neuralgia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Ophthalmic migraine
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
8 / 87 (9.20%) |
occurrences all number
|
8 |
4 |
Parkinson's disease
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Parkinsonism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Piriformis syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
0 |
Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Presyncope
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
5 |
2 |
Radicular pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
3 |
Sciatica
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
6 / 87 (6.90%) |
occurrences all number
|
3 |
4 |
Sensory loss
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Somnolence
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Syncope
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
6 |
2 |
Taste disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tension headache
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Tremor
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
8 / 87 (9.20%) |
occurrences all number
|
6 |
6 |
Eosinophilia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Increased tendency to bruise
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
3 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Microcytic anaemia
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Neutropenia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
White blood cell disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Ear and labyrinth disorders
|
|
|
Deafness bilateral
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Deafness neurosensory
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Ear discomfort
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Ear pain
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
1 |
Ear swelling
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Eustachian tube dysfunction
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Excessive cerumen production
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
3 / 87 (3.45%) |
occurrences all number
|
2 |
4 |
Hypoacusis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tinnitus
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
4 / 87 (4.60%) |
occurrences all number
|
2 |
3 |
Vertigo
|
|
|
subjects affected / exposed
|
13 / 284 (4.58%) |
5 / 87 (5.75%) |
occurrences all number
|
9 |
4 |
Vertigo positional
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Eye disorders
|
|
|
Blepharitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Cataract
|
|
|
subjects affected / exposed
|
18 / 284 (6.34%) |
5 / 87 (5.75%) |
occurrences all number
|
20 |
3 |
Chalazion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Corneal erosion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Diplopia
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Dry eye
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
4 / 87 (4.60%) |
occurrences all number
|
4 |
3 |
Eczema eyelids
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Entropion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Epiretinal membrane
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Eye irritation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Eye oedema
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Eye swelling
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Eyelid haematoma
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Glaucoma
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
2 |
Holmes-Adie pupil
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Iritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lacrimal mucocoele
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lacrimation decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lacrimation increased
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Macular degeneration
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
3 |
Macular hole
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Meibomian gland dysfunction
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Meibomianitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Metamorphopsia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Ocular hyperaemia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Ocular hypertension
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Photophobia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Retinal artery embolism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Retinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Retinopathy hypertensive
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Strabismus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Vision blurred
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
4 / 87 (4.60%) |
occurrences all number
|
1 |
3 |
Visual impairment
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Vitreous detachment
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vitreous floaters
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
0 / 87 (0.00%) |
occurrences all number
|
10 |
0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
20 / 284 (7.04%) |
8 / 87 (9.20%) |
occurrences all number
|
15 |
9 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
5 / 87 (5.75%) |
occurrences all number
|
7 |
7 |
Abdominal tenderness
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Anal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Aphthous ulcer
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Buccal polyp
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Constipation
|
|
|
subjects affected / exposed
|
22 / 284 (7.75%) |
11 / 87 (12.64%) |
occurrences all number
|
15 |
10 |
Defaecation urgency
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Dental caries
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Diarrhoea
|
|
|
subjects affected / exposed
|
37 / 284 (13.03%) |
13 / 87 (14.94%) |
occurrences all number
|
18 |
12 |
Diverticulum
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
6 / 87 (6.90%) |
occurrences all number
|
6 |
5 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Dry mouth
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
17 / 284 (5.99%) |
2 / 87 (2.30%) |
occurrences all number
|
7 |
2 |
Dysphagia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Enteritis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Eosinophilic oesophagitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Faeces discoloured
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Flatulence
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gastric disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Gastritis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
1 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
1 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Gastrointestinal scarring
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
8 / 87 (9.20%) |
occurrences all number
|
6 |
8 |
Gingival recession
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Glossitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
6 / 87 (6.90%) |
occurrences all number
|
5 |
3 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
1 |
Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
1 / 87 (1.15%) |
occurrences all number
|
6 |
2 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
6 / 87 (6.90%) |
occurrences all number
|
10 |
4 |
Leukoplakia oral
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Levator syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Malpositioned teeth
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nausea
|
|
|
subjects affected / exposed
|
28 / 284 (9.86%) |
12 / 87 (13.79%) |
occurrences all number
|
19 |
9 |
Oesophageal obstruction
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Pancreatic failure
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pancreatic steatosis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Post-tussive vomiting
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
8 |
0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Salivary gland disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Salivary gland enlargement
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Swollen tongue
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Terminal ileitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Tooth disorder
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Toothache
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
1 / 87 (1.15%) |
occurrences all number
|
8 |
0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Vomiting
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
3 / 87 (3.45%) |
occurrences all number
|
9 |
3 |
Skin and subcutaneous tissue disorders
|
|
|
Acne
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Actinic elastosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Actinic keratosis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
6 |
2 |
Alopecia
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Blister
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Cold sweat
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Dermatitis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Dry skin
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
0 |
Ecchymosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Eczema
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
5 / 87 (5.75%) |
occurrences all number
|
4 |
3 |
Eczema nummular
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Erythema
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
6 |
0 |
Hand dermatitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Ingrowing nail
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Intertrigo
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Keloid scar
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lichen planus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Lichenoid keratosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nail discolouration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nail dystrophy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Neurodermatitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Night sweats
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
1 |
Penile ulceration
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Petechiae
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pityriasis rosea
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Precancerous skin lesion
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pruritus
|
|
|
subjects affected / exposed
|
16 / 284 (5.63%) |
5 / 87 (5.75%) |
occurrences all number
|
16 |
6 |
Psoriasis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
5 |
0 |
Rash
|
|
|
subjects affected / exposed
|
17 / 284 (5.99%) |
6 / 87 (6.90%) |
occurrences all number
|
11 |
3 |
Rash erythematous
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Rash maculo-papular
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Rash papular
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Rash pruritic
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Rosacea
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
3 / 87 (3.45%) |
occurrences all number
|
1 |
2 |
Scab
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Seborrhoeic dermatitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Skin depigmentation
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Skin discolouration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Skin fissures
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Skin hyperpigmentation
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Skin induration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Skin lesion
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
1 / 87 (1.15%) |
occurrences all number
|
6 |
1 |
Skin ulcer
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Trichorrhexis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Urticaria
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Vitiligo
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Xanthoma
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Albuminuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Bladder cyst
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Calculus bladder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
2 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Dysuria
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
0 |
Glycosuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Haematuria
|
|
|
subjects affected / exposed
|
13 / 284 (4.58%) |
5 / 87 (5.75%) |
occurrences all number
|
12 |
4 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Hypertonic bladder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Incontinence
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Leukocyturia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Lower urinary tract symptoms
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Microalbuminuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Micturition disorder
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Micturition urgency
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Myoglobinuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
0 / 87 (0.00%) |
occurrences all number
|
4 |
0 |
Nephropathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nocturia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Pollakiuria
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Polyuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Proteinuria
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Renal cyst
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
2 / 87 (2.30%) |
occurrences all number
|
4 |
3 |
Renal failure
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Renal impairment
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
2 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Ureteral disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Urinary retention
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Urinary tract discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Urine flow decreased
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Endocrine disorders
|
|
|
Autoimmune thyroiditis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
3 / 87 (3.45%) |
occurrences all number
|
0 |
1 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
3 |
Thyroid cyst
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Thyroid mass
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
58 / 284 (20.42%) |
21 / 87 (24.14%) |
occurrences all number
|
53 |
28 |
Arthritis
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
4 / 87 (4.60%) |
occurrences all number
|
5 |
5 |
Arthritis reactive
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Articular calcification
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Axillary mass
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Back pain
|
|
|
subjects affected / exposed
|
45 / 284 (15.85%) |
16 / 87 (18.39%) |
occurrences all number
|
36 |
15 |
Bone atrophy
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Bone pain
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Bursitis
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
3 / 87 (3.45%) |
occurrences all number
|
10 |
0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Chondropathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Coccydynia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Costochondritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Enthesopathy
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Exostosis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Exostosis of jaw
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Femoroacetabular impingement
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Fibromyalgia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Finger deformity
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Foot deformity
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Groin pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Haematoma muscle
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Intervertebral disc disorder
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
5 |
0 |
Joint stiffness
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Joint swelling
|
|
|
subjects affected / exposed
|
11 / 284 (3.87%) |
1 / 87 (1.15%) |
occurrences all number
|
7 |
0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Loose body in joint
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle fatigue
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Muscle spasms
|
|
|
subjects affected / exposed
|
20 / 284 (7.04%) |
9 / 87 (10.34%) |
occurrences all number
|
19 |
8 |
Muscle tightness
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Muscular weakness
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
3 / 87 (3.45%) |
occurrences all number
|
6 |
3 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
1 / 87 (1.15%) |
occurrences all number
|
6 |
1 |
Musculoskeletal discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
2 |
Myalgia
|
|
|
subjects affected / exposed
|
39 / 284 (13.73%) |
14 / 87 (16.09%) |
occurrences all number
|
28 |
9 |
Neck pain
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
2 / 87 (2.30%) |
occurrences all number
|
4 |
2 |
Osteitis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
1 |
1 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
27 / 284 (9.51%) |
9 / 87 (10.34%) |
occurrences all number
|
18 |
8 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Osteopenia
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
33 / 284 (11.62%) |
9 / 87 (10.34%) |
occurrences all number
|
29 |
8 |
Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Patellofemoral pain syndrome
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Periarthritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Plantar fasciitis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
2 |
Shoulder deformity
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Sjogren's syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal deformity
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
8 / 284 (2.82%) |
0 / 87 (0.00%) |
occurrences all number
|
7 |
0 |
Spinal pain
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Spinal stenosis
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Spondyloarthropathy
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Spondylolisthesis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Synovial cyst
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Synovitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Temporomandibular joint syndrome
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Tendon discomfort
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Tendon pain
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Tendonitis
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
4 / 87 (4.60%) |
occurrences all number
|
3 |
4 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tenosynovitis stenosans
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
0 |
Trigger finger
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
6 |
0 |
Winged scapula
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Infections and infestations
|
|
|
Abscess
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Abscess of eyelid
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Acarodermatitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Asymptomatic bacteriuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Bacteriuria
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Balanitis candida
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Body tinea
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Bronchitis
|
|
|
subjects affected / exposed
|
23 / 284 (8.10%) |
6 / 87 (6.90%) |
occurrences all number
|
19 |
8 |
COVID-19
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
2 |
Candida infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Cellulitis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
4 |
1 |
Corneal infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Coronavirus infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Cystitis
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
6 / 87 (6.90%) |
occurrences all number
|
6 |
9 |
Cystitis klebsiella
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Dental fistula
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Device related infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
4 / 87 (4.60%) |
occurrences all number
|
5 |
4 |
Ear infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
7 / 87 (8.05%) |
occurrences all number
|
1 |
7 |
Ear lobe infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
External ear cellulitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Eye infection
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
1 |
Folliculitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Fungal infection
|
|
|
subjects affected / exposed
|
9 / 284 (3.17%) |
0 / 87 (0.00%) |
occurrences all number
|
6 |
0 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Furuncle
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
21 / 284 (7.39%) |
2 / 87 (2.30%) |
occurrences all number
|
12 |
1 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
6 / 87 (6.90%) |
occurrences all number
|
8 |
4 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Genital herpes
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Genital herpes simplex
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Genital infection fungal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Gingivitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
3 / 87 (3.45%) |
occurrences all number
|
0 |
3 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Hepatitis C
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Herpes simplex
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Herpes zoster
|
|
|
subjects affected / exposed
|
13 / 284 (4.58%) |
6 / 87 (6.90%) |
occurrences all number
|
13 |
3 |
Hordeolum
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
7 |
0 |
Impetigo
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Infected bite
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Infective exacerbation of bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Influenza
|
|
|
subjects affected / exposed
|
53 / 284 (18.66%) |
19 / 87 (21.84%) |
occurrences all number
|
42 |
20 |
Kidney infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Klebsiella infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
0 |
Laryngitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Localised infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
15 / 284 (5.28%) |
2 / 87 (2.30%) |
occurrences all number
|
23 |
4 |
Mastitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Myringitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
0 |
Nail infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal abscess
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
77 / 284 (27.11%) |
23 / 87 (26.44%) |
occurrences all number
|
73 |
21 |
Onychomycosis
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
0 / 87 (0.00%) |
occurrences all number
|
4 |
0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Oral fungal infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Oral herpes
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Oral infection
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Orchitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Otitis externa
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
3 |
0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
3 / 87 (3.45%) |
occurrences all number
|
1 |
0 |
Paronychia
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Perichondritis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
2 |
Pharyngitis
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
3 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Pneumonia
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
3 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Pulpitis dental
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Rash pustular
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
3 / 87 (3.45%) |
occurrences all number
|
2 |
2 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Retinitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Rhinitis
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
0 |
Root canal infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Sebaceous gland infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Sinusitis
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
7 / 87 (8.05%) |
occurrences all number
|
11 |
7 |
Skin infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
5 |
0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Suspected COVID-19
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Tinea cruris
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
2 / 87 (2.30%) |
occurrences all number
|
0 |
2 |
Tonsillitis
|
|
|
subjects affected / exposed
|
0 / 284 (0.00%) |
3 / 87 (3.45%) |
occurrences all number
|
0 |
0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
1 / 87 (1.15%) |
occurrences all number
|
3 |
1 |
Tooth infection
|
|
|
subjects affected / exposed
|
7 / 284 (2.46%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
2 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
33 / 284 (11.62%) |
9 / 87 (10.34%) |
occurrences all number
|
31 |
8 |
Urethritis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
42 / 284 (14.79%) |
12 / 87 (13.79%) |
occurrences all number
|
75 |
29 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vaginal infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Varicella zoster virus infection
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
0 |
1 |
Viral diarrhoea
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Vulvovaginal mycotic infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Wound infection
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
1 / 87 (1.15%) |
occurrences all number
|
2 |
1 |
Metabolism and nutrition disorders
|
|
|
Decreased appetite
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Dehydration
|
|
|
subjects affected / exposed
|
5 / 284 (1.76%) |
0 / 87 (0.00%) |
occurrences all number
|
4 |
0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
40 / 284 (14.08%) |
9 / 87 (10.34%) |
occurrences all number
|
37 |
7 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
10 / 284 (3.52%) |
6 / 87 (6.90%) |
occurrences all number
|
9 |
6 |
Dyslipidaemia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Fluid retention
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Folate deficiency
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Fructose intolerance
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
0 |
0 |
Glucose tolerance impaired
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
3 / 87 (3.45%) |
occurrences all number
|
2 |
2 |
Gout
|
|
|
subjects affected / exposed
|
14 / 284 (4.93%) |
5 / 87 (5.75%) |
occurrences all number
|
18 |
6 |
Haemochromatosis
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
0 / 87 (0.00%) |
occurrences all number
|
2 |
0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
2 / 284 (0.70%) |
2 / 87 (2.30%) |
occurrences all number
|
2 |
2 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
3 / 87 (3.45%) |
occurrences all number
|
3 |
2 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Impaired fasting glucose
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
1 / 87 (1.15%) |
occurrences all number
|
1 |
1 |
Increased appetite
|
|
|
subjects affected / exposed
|
3 / 284 (1.06%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Iron deficiency
|
|
|
subjects affected / exposed
|
4 / 284 (1.41%) |
2 / 87 (2.30%) |
occurrences all number
|
3 |
1 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
12 / 284 (4.23%) |
2 / 87 (2.30%) |
occurrences all number
|
7 |
2 |
Vitamin B12 deficiency
|
|
|
subjects affected / exposed
|
1 / 284 (0.35%) |
0 / 87 (0.00%) |
occurrences all number
|
1 |
0 |
Vitamin D deficiency
|
|
|
subjects affected / exposed
|
6 / 284 (2.11%) |
3 / 87 (3.45%) |
occurrences all number
|
4 |
2 |