Non-serious adverse events
|
Trebananib + Paclitaxel + Carboplatin |
Placebo + Paclitaxel + Carboplatin |
Total subjects affected by non serious adverse events
|
|
|
subjects affected / exposed
|
664 / 675 (98.37%) |
326 / 336 (97.02%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Benign neoplasm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Breast cancer
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cancer pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Malignant ascites
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Neoplasm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Respiratory papilloma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Seborrhoeic keratosis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Skin papilloma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Tumour haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Tumour pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular disorders
|
|
|
Bloody discharge
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
14 / 675 (2.07%) |
2 / 336 (0.60%) |
occurrences all number
|
16 |
2 |
Diastolic hypertension
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Embolism
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Flushing
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
11 / 336 (3.27%) |
occurrences all number
|
27 |
11 |
Haematoma
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
6 / 336 (1.79%) |
occurrences all number
|
5 |
7 |
Haemorrhage
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Hot flush
|
|
|
subjects affected / exposed
|
41 / 675 (6.07%) |
22 / 336 (6.55%) |
occurrences all number
|
60 |
26 |
Hyperaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hypertension
|
|
|
subjects affected / exposed
|
61 / 675 (9.04%) |
27 / 336 (8.04%) |
occurrences all number
|
89 |
38 |
Hypotension
|
|
|
subjects affected / exposed
|
26 / 675 (3.85%) |
10 / 336 (2.98%) |
occurrences all number
|
28 |
13 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Lymphocele
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
6 / 336 (1.79%) |
occurrences all number
|
6 |
7 |
Lymphoedema
|
|
|
subjects affected / exposed
|
79 / 675 (11.70%) |
11 / 336 (3.27%) |
occurrences all number
|
130 |
17 |
Lymphorrhoea
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Microangiopathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
4 / 336 (1.19%) |
occurrences all number
|
14 |
6 |
Pallor
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
4 |
Peripheral coldness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Phlebitis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
8 |
1 |
Phlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Raynaud's phenomenon
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Thrombosis
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
1 / 336 (0.30%) |
occurrences all number
|
6 |
1 |
Varicose vein
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vascular pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular rupture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
General disorders and administration site conditions
|
|
|
Adverse drug reaction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Application site pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Application site rash
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Application site reaction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Asthenia
|
|
|
subjects affected / exposed
|
117 / 675 (17.33%) |
70 / 336 (20.83%) |
occurrences all number
|
249 |
148 |
Axillary pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Catheter site bruise
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site dermatitis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Catheter site erosion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site erythema
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Catheter site extravasation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Catheter site haematoma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site inflammation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Catheter site necrosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site pain
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
5 / 336 (1.49%) |
occurrences all number
|
5 |
5 |
Catheter site rash
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
3 |
Catheter site related reaction
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Catheter site ulcer
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Catheter site vesicles
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
4 / 336 (1.19%) |
occurrences all number
|
11 |
4 |
Chest pain
|
|
|
subjects affected / exposed
|
23 / 675 (3.41%) |
19 / 336 (5.65%) |
occurrences all number
|
30 |
20 |
Chills
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
7 / 336 (2.08%) |
occurrences all number
|
16 |
10 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cyst
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Decreased activity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Discomfort
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Disease progression
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Early satiety
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Facial pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Extravasation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Fatigue
|
|
|
subjects affected / exposed
|
302 / 675 (44.74%) |
139 / 336 (41.37%) |
occurrences all number
|
671 |
293 |
Feeling cold
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
2 |
Gait disturbance
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Feeling hot
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
4 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
9 / 675 (1.33%) |
2 / 336 (0.60%) |
occurrences all number
|
10 |
2 |
Generalised oedema
|
|
|
subjects affected / exposed
|
85 / 675 (12.59%) |
9 / 336 (2.68%) |
occurrences all number
|
123 |
11 |
Hernia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
5 / 336 (1.49%) |
occurrences all number
|
2 |
6 |
Impaired healing
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Inflammation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Induration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Influenza like illness
|
|
|
subjects affected / exposed
|
22 / 675 (3.26%) |
14 / 336 (4.17%) |
occurrences all number
|
28 |
17 |
Infusion site bruising
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Infusion site erythema
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Infusion site extravasation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Infusion site oedema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Infusion site pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Infusion site pruritus
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Infusion site reaction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Injection site bruising
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Injection site extravasation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Injection site pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Injection site phlebitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Injection site reaction
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Localised oedema
|
|
|
subjects affected / exposed
|
367 / 675 (54.37%) |
86 / 336 (25.60%) |
occurrences all number
|
855 |
132 |
Malaise
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
11 / 336 (3.27%) |
occurrences all number
|
13 |
14 |
Mass
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Mucosal dryness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Mucosal inflammation
|
|
|
subjects affected / exposed
|
33 / 675 (4.89%) |
11 / 336 (3.27%) |
occurrences all number
|
47 |
14 |
Mucous membrane disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
3 |
Pain
|
|
|
subjects affected / exposed
|
73 / 675 (10.81%) |
33 / 336 (9.82%) |
occurrences all number
|
94 |
45 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Polyp
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pyrexia
|
|
|
subjects affected / exposed
|
65 / 675 (9.63%) |
40 / 336 (11.90%) |
occurrences all number
|
75 |
54 |
Sensation of foreign body
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Suprapubic pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Swelling
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Temperature intolerance
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Tenderness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Thirst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Thirst decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vascular complication associated with device
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Immune system disorders
|
|
|
Contrast media allergy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
14 / 336 (4.17%) |
occurrences all number
|
15 |
16 |
Cytokine release syndrome
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Food allergy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
40 / 675 (5.93%) |
16 / 336 (4.76%) |
occurrences all number
|
49 |
19 |
Seasonal allergy
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
3 |
Sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Social circumstances
|
|
|
Menopause
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Reproductive system and breast disorders
|
|
|
Atrophic vulvovaginitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bartholin's cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bleeding anovulatory
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Breast cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Breast disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Breast hyperplasia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Breast mass
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Breast pain
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
3 / 336 (0.89%) |
occurrences all number
|
7 |
3 |
Breast tenderness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cervix disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cervix erythema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cystocele
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Dyspareunia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Galactorrhoea
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Genital discharge
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Genital pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Genital rash
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Menopausal symptoms
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
4 / 336 (1.19%) |
occurrences all number
|
0 |
4 |
Menorrhagia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pelvic discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pelvic fluid collection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Pelvic pain
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
6 / 336 (1.79%) |
occurrences all number
|
11 |
7 |
Perineal ulceration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pruritus genital
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Retracted nipple
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vaginal discharge
|
|
|
subjects affected / exposed
|
11 / 675 (1.63%) |
6 / 336 (1.79%) |
occurrences all number
|
13 |
6 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
9 / 336 (2.68%) |
occurrences all number
|
8 |
9 |
Vaginal inflammation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Vaginal odour
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Vulva cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Vulvovaginal discomfort
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Vulvovaginal dryness
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Vulvovaginal pruritus
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acquired diaphragmatic eventration
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Anoxia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Asthma
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catarrh
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
7 |
3 |
Cough
|
|
|
subjects affected / exposed
|
99 / 675 (14.67%) |
49 / 336 (14.58%) |
occurrences all number
|
125 |
63 |
Cough decreased
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Dry throat
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Dysphonia
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
7 / 336 (2.08%) |
occurrences all number
|
6 |
8 |
Dyspnoea
|
|
|
subjects affected / exposed
|
115 / 675 (17.04%) |
39 / 336 (11.61%) |
occurrences all number
|
166 |
49 |
Dyspnoea at rest
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
35 / 675 (5.19%) |
12 / 336 (3.57%) |
occurrences all number
|
43 |
14 |
Emphysema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Epistaxis
|
|
|
subjects affected / exposed
|
23 / 675 (3.41%) |
16 / 336 (4.76%) |
occurrences all number
|
24 |
18 |
Haemoptysis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hiccups
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperventilation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hypoxia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Increased bronchial secretion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Increased upper airway secretion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Laryngeal inflammation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Laryngeal pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal congestion
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
5 / 336 (1.49%) |
occurrences all number
|
22 |
8 |
Nasal discomfort
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Nasal dryness
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Nasal mucosal disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nasal ulcer
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Oropharyngeal discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
44 / 675 (6.52%) |
22 / 336 (6.55%) |
occurrences all number
|
49 |
28 |
Paranasal sinus hypersecretion
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Pharyngeal inflammation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Pleural disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
59 / 675 (8.74%) |
7 / 336 (2.08%) |
occurrences all number
|
76 |
9 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Productive cough
|
|
|
subjects affected / exposed
|
15 / 675 (2.22%) |
8 / 336 (2.38%) |
occurrences all number
|
16 |
8 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
4 / 336 (1.19%) |
occurrences all number
|
1 |
4 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Rales
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Reflux laryngitis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Respiratory depression
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Respiratory tract congestion
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
3 |
2 |
Rhinitis allergic
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
3 / 336 (0.89%) |
occurrences all number
|
16 |
3 |
Rhinitis perennial
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Rhinorrhoea
|
|
|
subjects affected / exposed
|
30 / 675 (4.44%) |
8 / 336 (2.38%) |
occurrences all number
|
31 |
9 |
Sinus congestion
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Sinus disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Sinusitis noninfective
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sinus pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Sneezing
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sputum discoloured
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Throat irritation
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
0 / 336 (0.00%) |
occurrences all number
|
8 |
0 |
Tachypnoea
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Upper respiratory tract inflammation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Upper-airway cough syndrome
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
5 / 336 (1.49%) |
occurrences all number
|
8 |
6 |
Psychiatric disorders
|
|
|
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Adjustment disorder with depressed mood
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Affect lability
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Agitation
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
3 |
Anxiety
|
|
|
subjects affected / exposed
|
50 / 675 (7.41%) |
31 / 336 (9.23%) |
occurrences all number
|
56 |
40 |
Anxiety disorder due to a general medical condition
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Apathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
2 |
Confusional state
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Delirium
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Depressed mood
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
6 / 336 (1.79%) |
occurrences all number
|
6 |
6 |
Depression
|
|
|
subjects affected / exposed
|
35 / 675 (5.19%) |
20 / 336 (5.95%) |
occurrences all number
|
42 |
26 |
Fear
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hallucination
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Illusion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Insomnia
|
|
|
subjects affected / exposed
|
103 / 675 (15.26%) |
55 / 336 (16.37%) |
occurrences all number
|
137 |
76 |
Insomnia related to another mental condition
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Irritability
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Libido decreased
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Major depression
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Mood altered
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
5 |
Mood swings
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nervousness
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Nightmare
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Panic attack
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Restlessness
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
5 |
Sleep disorder
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
5 / 336 (1.49%) |
occurrences all number
|
2 |
6 |
Stress
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Suicidal ideation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Tearfulness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Product issues
|
|
|
Device failure
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Device issue
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Hepatobiliary disorders
|
|
|
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hepatic function abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Hepatic pain
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hepatic steatosis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hepatic vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hepatotoxicity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
1 / 336 (0.30%) |
occurrences all number
|
6 |
2 |
Hypertransaminasaemia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
5 / 336 (1.49%) |
occurrences all number
|
4 |
12 |
Investigations
|
|
|
Activated partial thromboplastin time abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Activated partial thromboplastin time prolonged
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
31 / 675 (4.59%) |
20 / 336 (5.95%) |
occurrences all number
|
68 |
27 |
Amylase increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
22 / 675 (3.26%) |
15 / 336 (4.46%) |
occurrences all number
|
43 |
21 |
Bacterial test
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Bilirubin conjugated increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Bleeding time prolonged
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Blood albumin abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood albumin decreased
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
10 / 336 (2.98%) |
occurrences all number
|
14 |
12 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
7 |
0 |
Blood calcium decreased
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Blood cholesterol increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood creatine increased
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
4 |
6 |
Blood creatinine abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
19 / 675 (2.81%) |
6 / 336 (1.79%) |
occurrences all number
|
32 |
8 |
Blood gases abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
6 |
Blood lactate dehydrogenase increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood lactic acid increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood magnesium decreased
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
7 / 336 (2.08%) |
occurrences all number
|
12 |
9 |
Blood magnesium increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Blood parathyroid hormone increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood phosphorus decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood phosphorus increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Blood potassium decreased
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
9 |
1 |
Blood sodium decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Blood sodium increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Blood uric acid abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood urine present
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
C-reactive protein abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
C-reactive protein decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
2 |
Cardiac murmur
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Culture urine positive
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Echocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Electrocardiogram abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Electrocardiogram t wave abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Fibrin d dimer increased
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gamma-glutamyltransferase increased
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
10 |
2 |
Glomerular filtration rate decreased
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
2 |
Glucose urine
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Glycosylated haemoglobin increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Granulocyte count decreased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
12 |
0 |
Haematocrit decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Haemoglobin
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
1 / 336 (0.30%) |
occurrences all number
|
24 |
3 |
Haemoglobin abnormal
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
31 / 675 (4.59%) |
9 / 336 (2.68%) |
occurrences all number
|
73 |
18 |
Heart rate decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Heart rate increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Heart rate irregular
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Hypophonesis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Intraocular pressure increased
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Liver function test
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Lymphocyte count decreased
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
7 |
6 |
Nerve conduction studies abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Neutrophil count
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Neutrophil count abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Neutrophil count decreased
|
|
|
subjects affected / exposed
|
46 / 675 (6.81%) |
21 / 336 (6.25%) |
occurrences all number
|
121 |
73 |
Neutrophil count increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Nitrite urine present
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pain assessment
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
3 |
Platelet count decreased
|
|
|
subjects affected / exposed
|
84 / 675 (12.44%) |
34 / 336 (10.12%) |
occurrences all number
|
263 |
86 |
Platelet count increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Protein total
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Protein total abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Protein total decreased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Protein urine
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pulmonary physical examination abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Red blood cell count decreased
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Serum ferritin decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Urine analysis abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
3 |
Urine output decreased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Urine output increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Urine protein, quantitative
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vitamin d decreased
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Waist circumference increased
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Weight decreased
|
|
|
subjects affected / exposed
|
28 / 675 (4.15%) |
19 / 336 (5.65%) |
occurrences all number
|
52 |
41 |
Weight increased
|
|
|
subjects affected / exposed
|
46 / 675 (6.81%) |
19 / 336 (5.65%) |
occurrences all number
|
107 |
27 |
White blood cell analysis abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
White blood cell count
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
White blood cell count abnormal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
White blood cell count decreased
|
|
|
subjects affected / exposed
|
48 / 675 (7.11%) |
19 / 336 (5.65%) |
occurrences all number
|
199 |
87 |
White blood cell count increased
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
White blood cells urine positive
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Injury, poisoning and procedural complications
|
|
|
Animal scratch
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Arthropod bite
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
4 / 336 (1.19%) |
occurrences all number
|
1 |
4 |
Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Arthropod sting
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Chest crushing
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Contusion
|
|
|
subjects affected / exposed
|
16 / 675 (2.37%) |
11 / 336 (3.27%) |
occurrences all number
|
23 |
14 |
Contrast media reaction
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Epicondylitis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Eye injury
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Excoriation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Fall
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
1 / 336 (0.30%) |
occurrences all number
|
12 |
2 |
Foot fracture
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Foreign body
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Gastrointestinal disorder postoperative
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gastrointestinal stoma complication
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Haematuria traumatic
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hand fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Head injury
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Hip fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Incision site erythema
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Incision site oedema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Incision site pain
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
2 / 336 (0.60%) |
occurrences all number
|
9 |
2 |
Incisional hernia, obstructive
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Infusion related reaction
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
8 / 336 (2.38%) |
occurrences all number
|
25 |
9 |
Injury
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Laceration
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Ligament injury
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Limb injury
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Meniscus injury
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Nerve injury
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Pneumothorax traumatic
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Post procedural complication
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Postoperative fever
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Postoperative hernia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Postoperative wound complication
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Procedural dizziness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Procedural nausea
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
5 / 336 (1.49%) |
occurrences all number
|
11 |
5 |
Procedural pain
|
|
|
subjects affected / exposed
|
43 / 675 (6.37%) |
22 / 336 (6.55%) |
occurrences all number
|
46 |
22 |
Rib fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Skin abrasion
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
3 |
Stoma site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Stoma site inflammation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Stoma site irritation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Stoma site reaction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Tooth fracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Venous injury
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Wound
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Wound complication
|
|
|
subjects affected / exposed
|
11 / 675 (1.63%) |
7 / 336 (2.08%) |
occurrences all number
|
12 |
7 |
Wound decomposition
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Wound evisceration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Wound secretion
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
3 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Congenital, familial and genetic disorders
|
|
|
Bronchogenic cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Familial tremor
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiac disorders
|
|
|
Angina pectoris
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
3 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Bradycardia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Cardiac failure
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cardiac flutter
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Palpitations
|
|
|
subjects affected / exposed
|
20 / 675 (2.96%) |
16 / 336 (4.76%) |
occurrences all number
|
23 |
17 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
3 / 336 (0.89%) |
occurrences all number
|
7 |
3 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Tachycardia
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
10 / 336 (2.98%) |
occurrences all number
|
13 |
11 |
Tachycardia foetal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Ventricular flutter
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nervous system disorders
|
|
|
Amnesia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Anosmia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Aphasia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Aphonia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Ataxia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Aura
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Balance disorder
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
4 / 336 (1.19%) |
occurrences all number
|
3 |
5 |
Burning sensation
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
3 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
4 / 336 (1.19%) |
occurrences all number
|
0 |
4 |
Cranial nerve disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
2 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Disturbance in attention
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Dizziness
|
|
|
subjects affected / exposed
|
128 / 675 (18.96%) |
48 / 336 (14.29%) |
occurrences all number
|
211 |
68 |
Dizziness exertional
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Dizziness postural
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
1 / 336 (0.30%) |
occurrences all number
|
10 |
1 |
Dysaesthesia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
5 |
4 |
Dysarthria
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Dysgeusia
|
|
|
subjects affected / exposed
|
71 / 675 (10.52%) |
37 / 336 (11.01%) |
occurrences all number
|
84 |
50 |
Dyskinesia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Head discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Headache
|
|
|
subjects affected / exposed
|
121 / 675 (17.93%) |
51 / 336 (15.18%) |
occurrences all number
|
182 |
90 |
Horner's syndrome
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Hyperaesthesia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Hypoaesthesia
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
10 / 336 (2.98%) |
occurrences all number
|
33 |
12 |
Lethargy
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Memory impairment
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
6 / 336 (1.79%) |
occurrences all number
|
7 |
6 |
Mental impairment
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Meralgia paraesthetica
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Migraine
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Migraine with aura
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Motor dysfunction
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Neuralgia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
11 |
0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
215 / 675 (31.85%) |
103 / 336 (30.65%) |
occurrences all number
|
363 |
173 |
Neurotoxicity
|
|
|
subjects affected / exposed
|
19 / 675 (2.81%) |
12 / 336 (3.57%) |
occurrences all number
|
30 |
23 |
Olfactory nerve disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Paraesthesia
|
|
|
subjects affected / exposed
|
74 / 675 (10.96%) |
41 / 336 (12.20%) |
occurrences all number
|
101 |
66 |
Parosmia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Peripheral motor neuropathy
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
2 / 336 (0.60%) |
occurrences all number
|
8 |
2 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Peripheral sensory neuropathy
|
|
|
subjects affected / exposed
|
139 / 675 (20.59%) |
65 / 336 (19.35%) |
occurrences all number
|
208 |
111 |
Peroneal nerve palsy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
22 / 675 (3.26%) |
16 / 336 (4.76%) |
occurrences all number
|
28 |
27 |
Poor quality sleep
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Post herpetic neuralgia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Post-traumatic headache
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Presyncope
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Radicular pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Restless legs syndrome
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
9 / 336 (2.68%) |
occurrences all number
|
15 |
10 |
Reversed hot-cold sensation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sciatica
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
4 / 336 (1.19%) |
occurrences all number
|
11 |
5 |
Seizure
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sensory disturbance
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Sinus headache
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Somnolence
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
5 / 336 (1.49%) |
occurrences all number
|
8 |
6 |
Speech disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Syncope
|
|
|
subjects affected / exposed
|
18 / 675 (2.67%) |
10 / 336 (2.98%) |
occurrences all number
|
22 |
10 |
Tension headache
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Thoracic outlet syndrome
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Toxic neuropathy
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
3 |
Tremor
|
|
|
subjects affected / exposed
|
11 / 675 (1.63%) |
5 / 336 (1.49%) |
occurrences all number
|
12 |
7 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
201 / 675 (29.78%) |
112 / 336 (33.33%) |
occurrences all number
|
556 |
306 |
Anaemia vitamin b12 deficiency
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
2 / 336 (0.60%) |
occurrences all number
|
5 |
2 |
Haematotoxicity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hypercoagulation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hypochromasia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Increased tendency to bruise
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Leukopenia
|
|
|
subjects affected / exposed
|
116 / 675 (17.19%) |
58 / 336 (17.26%) |
occurrences all number
|
466 |
205 |
Lymph node pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Lymphopenia
|
|
|
subjects affected / exposed
|
9 / 675 (1.33%) |
4 / 336 (1.19%) |
occurrences all number
|
43 |
12 |
Neutropenia
|
|
|
subjects affected / exposed
|
296 / 675 (43.85%) |
157 / 336 (46.73%) |
occurrences all number
|
1104 |
532 |
Normochromic normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
4 |
7 |
Platelet disorder
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
8 |
Thrombasthenia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
131 / 675 (19.41%) |
59 / 336 (17.56%) |
occurrences all number
|
340 |
160 |
Thrombocytosis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
White blood cell disorder
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
12 |
2 |
Ear and labyrinth disorders
|
|
|
Cerumen impaction
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Conductive deafness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Deafness
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
4 |
Deafness bilateral
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Ear congestion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Ear discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Ear disorder
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Ear pain
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
6 / 336 (1.79%) |
occurrences all number
|
17 |
7 |
Eustachian tube dysfunction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Eustachian tube patulous
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hypoacusis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Motion sickness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ototoxicity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Tinnitus
|
|
|
subjects affected / exposed
|
26 / 675 (3.85%) |
6 / 336 (1.79%) |
occurrences all number
|
28 |
9 |
Vertigo
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
4 / 336 (1.19%) |
occurrences all number
|
25 |
8 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Eye disorders
|
|
|
Age-related macular degeneration
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Amblyopia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Asthenopia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
3 / 336 (0.89%) |
occurrences all number
|
0 |
3 |
Blepharospasm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cataract
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Chalazion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Conjunctival haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
3 |
Conjunctival oedema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Dacryostenosis acquired
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Diplopia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Dry eye
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
9 / 336 (2.68%) |
occurrences all number
|
30 |
9 |
Eye allergy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Eye discharge
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Eye disorder
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Eye haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Eye irritation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
4 |
Eye movement disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Eye pain
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Eye pruritus
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Eyelid irritation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Eyelid ptosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Foreign body sensation in eyes
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Glaucoma
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Hypermetropia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lacrimation increased
|
|
|
subjects affected / exposed
|
19 / 675 (2.81%) |
2 / 336 (0.60%) |
occurrences all number
|
21 |
2 |
Maculopathy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ocular discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ocular hyperaemia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Ocular hypertension
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Photophobia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Photopsia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Presbyopia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Pterygium
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Punctate keratitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Retinal vein occlusion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Scleral cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Scleral disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Scleral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vision blurred
|
|
|
subjects affected / exposed
|
74 / 675 (10.96%) |
24 / 336 (7.14%) |
occurrences all number
|
85 |
30 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
1 / 336 (0.30%) |
occurrences all number
|
8 |
1 |
Vitreous detachment
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Visual impairment
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
4 / 336 (1.19%) |
occurrences all number
|
9 |
4 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vitreous floaters
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Gastrointestinal disorders
|
|
|
Abdominal discomfort
|
|
|
subjects affected / exposed
|
18 / 675 (2.67%) |
11 / 336 (3.27%) |
occurrences all number
|
20 |
11 |
Abdominal distension
|
|
|
subjects affected / exposed
|
71 / 675 (10.52%) |
25 / 336 (7.44%) |
occurrences all number
|
95 |
27 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
212 / 675 (31.41%) |
109 / 336 (32.44%) |
occurrences all number
|
372 |
179 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
26 / 675 (3.85%) |
10 / 336 (2.98%) |
occurrences all number
|
31 |
11 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
72 / 675 (10.67%) |
35 / 336 (10.42%) |
occurrences all number
|
102 |
47 |
Abdominal rigidity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Abdominal tenderness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Anal fissure
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Anal incontinence
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Anal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Anal pruritus
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Anal sphincter atony
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Anal ulcer
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Anorectal discomfort
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Aphthous ulcer
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
7 |
6 |
Ascites
|
|
|
subjects affected / exposed
|
91 / 675 (13.48%) |
21 / 336 (6.25%) |
occurrences all number
|
172 |
29 |
Bowel movement irregularity
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Change of bowel habit
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Chapped lips
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Cheilitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Constipation
|
|
|
subjects affected / exposed
|
267 / 675 (39.56%) |
143 / 336 (42.56%) |
occurrences all number
|
397 |
207 |
Defaecation urgency
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Dental caries
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
5 / 336 (1.49%) |
occurrences all number
|
3 |
5 |
Diarrhoea
|
|
|
subjects affected / exposed
|
238 / 675 (35.26%) |
116 / 336 (34.52%) |
occurrences all number
|
423 |
203 |
Diarrhoea haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Douglas' pouch mass
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Dry mouth
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
11 / 336 (3.27%) |
occurrences all number
|
27 |
12 |
Dyschezia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Dyspepsia
|
|
|
subjects affected / exposed
|
78 / 675 (11.56%) |
33 / 336 (9.82%) |
occurrences all number
|
96 |
38 |
Dysphagia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Enteritis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
5 / 336 (1.49%) |
occurrences all number
|
9 |
5 |
Eructation
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Faecaloma
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Faeces soft
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
3 |
Flatulence
|
|
|
subjects affected / exposed
|
26 / 675 (3.85%) |
9 / 336 (2.68%) |
occurrences all number
|
30 |
10 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Frequent bowel movements
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gastric disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Gastritis
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
5 / 336 (1.49%) |
occurrences all number
|
8 |
5 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Gastrointestinal motility disorder
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
3 |
Gastrointestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Gastrointestinal pain
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Gastrointestinal sounds abnormal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
22 / 675 (3.26%) |
9 / 336 (2.68%) |
occurrences all number
|
24 |
10 |
Gingival bleeding
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
4 |
Gingival pain
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
1 / 336 (0.30%) |
occurrences all number
|
6 |
1 |
Gingival swelling
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Haematochezia
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
3 / 336 (0.89%) |
occurrences all number
|
5 |
3 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
19 / 675 (2.81%) |
5 / 336 (1.49%) |
occurrences all number
|
23 |
5 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hyperchlorhydria
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Ileus
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
2 / 336 (0.60%) |
occurrences all number
|
9 |
3 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Intestinal fistula
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Large intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Lip blister
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Lip pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Lip ulceration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Mouth haemorrhage
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Nausea
|
|
|
subjects affected / exposed
|
387 / 675 (57.33%) |
205 / 336 (61.01%) |
occurrences all number
|
835 |
375 |
Odynophagia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
6 |
Oesophageal pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
3 / 336 (0.89%) |
occurrences all number
|
4 |
3 |
Oral disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Oral mucosal erythema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Oral mucosal exfoliation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Oral pain
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
6 / 336 (1.79%) |
occurrences all number
|
4 |
7 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Parotid duct obstruction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Perianal erythema
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Periodontal disease
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Proctalgia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
3 / 336 (0.89%) |
occurrences all number
|
4 |
3 |
Rectal discharge
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Rectal fissure
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
4 / 336 (1.19%) |
occurrences all number
|
8 |
5 |
Retching
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Salivary gland pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Salivary hypersecretion
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Sensitivity of teeth
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
2 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Stomatitis
|
|
|
subjects affected / exposed
|
41 / 675 (6.07%) |
21 / 336 (6.25%) |
occurrences all number
|
50 |
21 |
Subileus
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Tongue coated
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Tongue discolouration
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
2 |
Tooth disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Tooth loss
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Toothache
|
|
|
subjects affected / exposed
|
22 / 675 (3.26%) |
11 / 336 (3.27%) |
occurrences all number
|
25 |
12 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Vomiting
|
|
|
subjects affected / exposed
|
233 / 675 (34.52%) |
109 / 336 (32.44%) |
occurrences all number
|
383 |
176 |
Skin and subcutaneous tissue disorders
|
|
|
Alopecia
|
|
|
subjects affected / exposed
|
363 / 675 (53.78%) |
179 / 336 (53.27%) |
occurrences all number
|
507 |
257 |
Acne
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
7 |
1 |
Alopecia totalis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
4 / 336 (1.19%) |
occurrences all number
|
1 |
4 |
Alopecia areata
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
6 / 336 (1.79%) |
occurrences all number
|
2 |
9 |
Blister
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Dermal cyst
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Dermatitis
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
4 |
Dermatitis acneiform
|
|
|
subjects affected / exposed
|
9 / 675 (1.33%) |
4 / 336 (1.19%) |
occurrences all number
|
11 |
6 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Dermatitis bullous
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Dry skin
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
15 / 336 (4.46%) |
occurrences all number
|
27 |
15 |
Ecchymosis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Eczema
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Erythema
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
13 / 336 (3.87%) |
occurrences all number
|
33 |
15 |
Erythema multiforme
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Exfoliative rash
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
0 / 336 (0.00%) |
occurrences all number
|
9 |
0 |
Excessive granulation tissue
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hair growth abnormal
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
3 |
Hidradenitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
8 / 336 (2.38%) |
occurrences all number
|
8 |
9 |
Hirsutism
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Ingrowing nail
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Lichen sclerosus
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Madarosis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Nail bed inflammation
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nail discolouration
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
3 |
3 |
Nail disorder
|
|
|
subjects affected / exposed
|
17 / 675 (2.52%) |
7 / 336 (2.08%) |
occurrences all number
|
21 |
7 |
Nail dystrophy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Neurodermatitis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Night sweats
|
|
|
subjects affected / exposed
|
11 / 675 (1.63%) |
3 / 336 (0.89%) |
occurrences all number
|
12 |
3 |
Onychoclasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
6 / 336 (1.79%) |
occurrences all number
|
1 |
6 |
Onychomadesis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Pain of skin
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
3 |
Palmar-plantar erythrodysaesthesia syndrome
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
2 / 336 (0.60%) |
occurrences all number
|
5 |
2 |
Panniculitis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Papule
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Petechiae
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
4 |
4 |
Photosensitivity reaction
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pigmentation disorder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Piloerection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Pityriasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pruritus
|
|
|
subjects affected / exposed
|
69 / 675 (10.22%) |
29 / 336 (8.63%) |
occurrences all number
|
84 |
41 |
Pruritus allergic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Pruritus generalised
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
4 |
4 |
Psoriasis
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Purpura
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
2 |
Rash
|
|
|
subjects affected / exposed
|
77 / 675 (11.41%) |
49 / 336 (14.58%) |
occurrences all number
|
101 |
66 |
Rash erythematous
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
4 |
Rash generalised
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
4 / 336 (1.19%) |
occurrences all number
|
0 |
4 |
Rash macular
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Rash maculo-papular
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
2 |
Rash papular
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
5 |
Rash pruritic
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
5 / 336 (1.49%) |
occurrences all number
|
15 |
5 |
Rash vesicular
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Rosacea
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Scab
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Scar pain
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Seborrhoeic dermatitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Skin atrophy
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Skin depigmentation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Skin discolouration
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Skin disorder
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Skin exfoliation
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Skin fissures
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Skin hyperpigmentation
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
3 |
3 |
Skin irritation
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
3 / 336 (0.89%) |
occurrences all number
|
0 |
4 |
Skin lesion
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
3 |
3 |
Skin mass
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Skin reaction
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Skin tightness
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Skin toxicity
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Skin ulcer
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
8 |
0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Sweat gland disorder
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Swelling face
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Telangiectasia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
2 |
Toxic skin eruption
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Umbilical discharge
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Urticaria
|
|
|
subjects affected / exposed
|
18 / 675 (2.67%) |
12 / 336 (3.57%) |
occurrences all number
|
21 |
14 |
Urticaria aquagenic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Xeroderma
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Albuminuria
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Bladder pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Bladder prolapse
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Bladder spasm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Calculus urinary
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Cystitis noninfective
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cystitis-like symptom
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Dysuria
|
|
|
subjects affected / exposed
|
29 / 675 (4.30%) |
15 / 336 (4.46%) |
occurrences all number
|
37 |
18 |
Glycosuria
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Haematuria
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
2 / 336 (0.60%) |
occurrences all number
|
6 |
2 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
0 / 336 (0.00%) |
occurrences all number
|
7 |
0 |
Incontinence
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Micturition disorder
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Micturition urgency
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
4 / 336 (1.19%) |
occurrences all number
|
7 |
4 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
3 |
Neurogenic bladder
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Nocturia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Oliguria
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
1 / 336 (0.30%) |
occurrences all number
|
5 |
1 |
Pollakiuria
|
|
|
subjects affected / exposed
|
18 / 675 (2.67%) |
10 / 336 (2.98%) |
occurrences all number
|
19 |
10 |
Polyuria
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Proteinuria
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
9 / 336 (2.68%) |
occurrences all number
|
28 |
11 |
Pyelocaliectasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Renal aneurysm
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Renal failure
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Renal pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Renal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Stress urinary incontinence
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Urethral pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Urge incontinence
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Urinary bladder rupture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
16 / 675 (2.37%) |
12 / 336 (3.57%) |
occurrences all number
|
20 |
15 |
Urinary retention
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Urinary tract disorder
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Urinary tract pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Urine abnormality
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Endocrine disorders
|
|
|
Cushing's syndrome
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Goitre
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hyperparathyroidism primary
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
4 |
4 |
Thyroid cyst
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
189 / 675 (28.00%) |
92 / 336 (27.38%) |
occurrences all number
|
380 |
173 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Back pain
|
|
|
subjects affected / exposed
|
90 / 675 (13.33%) |
59 / 336 (17.56%) |
occurrences all number
|
124 |
77 |
Bone cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bone loss
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bone pain
|
|
|
subjects affected / exposed
|
51 / 675 (7.56%) |
30 / 336 (8.93%) |
occurrences all number
|
66 |
43 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Coccydynia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Exostosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Fistula
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Flank pain
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
4 / 336 (1.19%) |
occurrences all number
|
15 |
4 |
Fracture pain
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Groin pain
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
3 / 336 (0.89%) |
occurrences all number
|
15 |
3 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Joint effusion
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Joint stiffness
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
3 |
Joint swelling
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Limb discomfort
|
|
|
subjects affected / exposed
|
6 / 675 (0.89%) |
6 / 336 (1.79%) |
occurrences all number
|
7 |
10 |
Muscle contracture
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle fatigue
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Muscle rigidity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
2 / 336 (0.60%) |
occurrences all number
|
0 |
2 |
Muscle spasms
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
19 / 336 (5.65%) |
occurrences all number
|
24 |
23 |
Muscle tightness
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
33 / 675 (4.89%) |
17 / 336 (5.06%) |
occurrences all number
|
41 |
21 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
8 / 336 (2.38%) |
occurrences all number
|
13 |
8 |
Musculoskeletal discomfort
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
38 / 675 (5.63%) |
35 / 336 (10.42%) |
occurrences all number
|
47 |
50 |
Musculoskeletal stiffness
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
3 / 336 (0.89%) |
occurrences all number
|
5 |
5 |
Myalgia
|
|
|
subjects affected / exposed
|
125 / 675 (18.52%) |
64 / 336 (19.05%) |
occurrences all number
|
219 |
117 |
Myopathy
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Myositis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Neck mass
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Neck pain
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
7 / 336 (2.08%) |
occurrences all number
|
10 |
8 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
4 / 336 (1.19%) |
occurrences all number
|
3 |
4 |
Osteomalacia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
3 |
Osteopenia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
3 / 336 (0.89%) |
occurrences all number
|
1 |
3 |
Pain in extremity
|
|
|
subjects affected / exposed
|
118 / 675 (17.48%) |
45 / 336 (13.39%) |
occurrences all number
|
186 |
59 |
Pain in jaw
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
5 / 336 (1.49%) |
occurrences all number
|
8 |
5 |
Periarthritis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Plantar fasciitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Rib deformity
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sarcopenia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Sjogren's syndrome
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Soft tissue mass
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Spinal pain
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
3 / 336 (0.89%) |
occurrences all number
|
2 |
3 |
Synovial cyst
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Temporomandibular joint syndrome
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Tendon pain
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Tendonitis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
4 |
4 |
Tenosynovitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Torticollis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Abdominal wall infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Asymptomatic bacteriuria
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Bacterial vaginosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bacteriuria
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Body tinea
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Breast abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Bronchitis
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
5 / 336 (1.49%) |
occurrences all number
|
11 |
5 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Catheter site cellulitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Candida infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Cellulitis
|
|
|
subjects affected / exposed
|
13 / 675 (1.93%) |
2 / 336 (0.60%) |
occurrences all number
|
14 |
2 |
Catheter site infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Clostridium colitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
6 / 336 (1.79%) |
occurrences all number
|
13 |
6 |
Cystitis
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
6 / 336 (1.79%) |
occurrences all number
|
25 |
7 |
Cystitis bacterial
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Cystitis escherichia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Device related infection
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
3 / 336 (0.89%) |
occurrences all number
|
6 |
3 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Ear infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Ear lobe infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Empyema
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Erysipeloid
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Eye infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Folliculitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
2 / 336 (0.60%) |
occurrences all number
|
2 |
2 |
Fungal infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Fungal skin infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
2 / 336 (0.60%) |
occurrences all number
|
1 |
2 |
Furuncle
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
2 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
5 / 336 (1.49%) |
occurrences all number
|
8 |
5 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
0 / 336 (0.00%) |
occurrences all number
|
8 |
0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Genital candidiasis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Genital herpes
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Genitourinary tract infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Gingivitis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Groin abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Helicobacter infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hepatitis c
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Herpes dermatitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Herpes simplex
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Herpes virus infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Herpes zoster
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
2 / 336 (0.60%) |
occurrences all number
|
10 |
2 |
Impetigo
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Hordeolum
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Infected lymphocele
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Incision site infection
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Infection
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
2 / 336 (0.60%) |
occurrences all number
|
8 |
2 |
Infection parasitic
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Influenza
|
|
|
subjects affected / exposed
|
18 / 675 (2.67%) |
11 / 336 (3.27%) |
occurrences all number
|
19 |
12 |
Injection site infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Kidney infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Laryngitis
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
2 / 336 (0.60%) |
occurrences all number
|
8 |
2 |
Lip infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Localised infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
2 |
Lung infection
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Lymphangitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Mastitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Mucosal infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Nail infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
51 / 675 (7.56%) |
31 / 336 (9.23%) |
occurrences all number
|
78 |
44 |
Onychomycosis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
3 / 336 (0.89%) |
occurrences all number
|
3 |
3 |
Oral fungal infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Oral herpes
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
4 / 336 (1.19%) |
occurrences all number
|
10 |
4 |
Paronychia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Pelvic abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Parotitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Peritonitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Periodontitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
4 / 336 (1.19%) |
occurrences all number
|
5 |
5 |
Pharyngitis bacterial
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Pharyngotonsillitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Pneumonia
|
|
|
subjects affected / exposed
|
9 / 675 (1.33%) |
1 / 336 (0.30%) |
occurrences all number
|
9 |
5 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
5 |
0 |
Pulpitis dental
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Pyuria
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Rash pustular
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
12 / 675 (1.78%) |
1 / 336 (0.30%) |
occurrences all number
|
14 |
1 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Rhinitis
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
9 / 336 (2.68%) |
occurrences all number
|
14 |
10 |
Sepsis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Sinusitis
|
|
|
subjects affected / exposed
|
16 / 675 (2.37%) |
5 / 336 (1.49%) |
occurrences all number
|
18 |
7 |
Skin candida
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
2 |
Skin infection
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Staphylococcal scalded skin syndrome
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Stoma site abscess
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Stoma site infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Superinfection
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Tonsillitis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Tinea pedis
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
10 / 675 (1.48%) |
6 / 336 (1.79%) |
occurrences all number
|
14 |
7 |
Tooth infection
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
2 / 336 (0.60%) |
occurrences all number
|
5 |
2 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
36 / 675 (5.33%) |
11 / 336 (3.27%) |
occurrences all number
|
42 |
16 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
7 / 675 (1.04%) |
2 / 336 (0.60%) |
occurrences all number
|
8 |
2 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
85 / 675 (12.59%) |
36 / 336 (10.71%) |
occurrences all number
|
135 |
52 |
Urinary tract infection fungal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Urosepsis
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vaginal abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Vaginal infection
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
2 |
Vaginitis bacterial
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Viral diarrhoea
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vulvovaginal candidiasis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Vulvovaginal mycotic infection
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
1 |
1 |
Wound abscess
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Wound infection
|
|
|
subjects affected / exposed
|
5 / 675 (0.74%) |
0 / 336 (0.00%) |
occurrences all number
|
6 |
0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Metabolism and nutrition disorders
|
|
|
Abnormal loss of weight
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
175 / 675 (25.93%) |
89 / 336 (26.49%) |
occurrences all number
|
278 |
143 |
Dehydration
|
|
|
subjects affected / exposed
|
34 / 675 (5.04%) |
13 / 336 (3.87%) |
occurrences all number
|
52 |
14 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Fluid imbalance
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Fluid retention
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Food craving
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Gout
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Hyper hdl cholesterolaemia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
1 / 336 (0.30%) |
occurrences all number
|
4 |
1 |
Hypercholesterolaemia
|
|
|
subjects affected / exposed
|
8 / 675 (1.19%) |
1 / 336 (0.30%) |
occurrences all number
|
8 |
1 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
30 / 675 (4.44%) |
12 / 336 (3.57%) |
occurrences all number
|
57 |
31 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
11 / 675 (1.63%) |
8 / 336 (2.38%) |
occurrences all number
|
33 |
8 |
Hyperlipidaemia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
0 / 336 (0.00%) |
occurrences all number
|
7 |
0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
40 / 675 (5.93%) |
9 / 336 (2.68%) |
occurrences all number
|
75 |
13 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
24 / 675 (3.56%) |
9 / 336 (2.68%) |
occurrences all number
|
43 |
12 |
Hypochloraemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
115 / 675 (17.04%) |
46 / 336 (13.69%) |
occurrences all number
|
220 |
70 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
89 / 675 (13.19%) |
41 / 336 (12.20%) |
occurrences all number
|
168 |
79 |
Hypometabolism
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
21 / 675 (3.11%) |
12 / 336 (3.57%) |
occurrences all number
|
32 |
19 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
4 / 675 (0.59%) |
2 / 336 (0.60%) |
occurrences all number
|
4 |
3 |
Hypoproteinaemia
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Hyposideraemia
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Increased appetite
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
4 |
0 |
Iron deficiency
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Magnesium deficiency
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Malnutrition
|
|
|
subjects affected / exposed
|
3 / 675 (0.44%) |
0 / 336 (0.00%) |
occurrences all number
|
3 |
0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Polydipsia
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
0 / 336 (0.00%) |
occurrences all number
|
2 |
0 |
Protein deficiency
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
2 |
1 |
Vitamin b complex deficiency
|
|
|
subjects affected / exposed
|
0 / 675 (0.00%) |
1 / 336 (0.30%) |
occurrences all number
|
0 |
1 |
Vitamin d deficiency
|
|
|
subjects affected / exposed
|
2 / 675 (0.30%) |
1 / 336 (0.30%) |
occurrences all number
|
3 |
1 |
Vitamin k deficiency
|
|
|
subjects affected / exposed
|
1 / 675 (0.15%) |
0 / 336 (0.00%) |
occurrences all number
|
1 |
0 |