Non-serious adverse events
|
Arm A |
All Subjects |
Arm B (Observation only) |
Total subjects affected by non serious adverse events
|
|
|
|
subjects affected / exposed
|
133 / 138 (96.38%) |
643 / 692 (92.92%) |
133 / 138 (96.38%) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
17 / 692 (2.46%) |
5 / 138 (3.62%) |
occurrences all number
|
5 |
19 |
5 |
Bowen's disease
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
3 |
2 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
8 |
1 |
Acrochordon
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Lobular breast carcinoma in situ
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Melanocytic naevus
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Paget's disease of nipple
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Seborrhoeic keratosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Skin papilloma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
6 |
2 |
Uterine leiomyoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Sweat gland tumour
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Leiomyoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Large intestine benign neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Large cell lung cancer
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Keratoacanthoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Bladder transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Vascular disorders
|
|
|
|
Angiopathy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Aortic arteriosclerosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Aortic aneurysm
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Surgical and medical procedures
|
|
|
|
Hypotension
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
19 / 692 (2.75%) |
3 / 138 (2.17%) |
occurrences all number
|
2 |
21 |
3 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Poor venous access
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tooth extraction
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Astringent therapy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
0 |
1 |
Central venous catheter removal
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
0 |
1 |
Cholecystectomy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
0 |
1 |
Foot operation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Hip arthroplasty
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Mass excision
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
0 |
1 |
Nephrostomy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Shoulder arthroplasty
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Skin neoplasm excision
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
0 |
1 |
Venous thrombosis limb
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Varicose vein
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
1 |
Varicose ulceration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Thrombophlebitis superficial
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Subclavian vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Spider vein
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Phlebitis superficial
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
3 / 138 (2.17%) |
occurrences all number
|
2 |
7 |
3 |
Peripheral venous disease
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
5 |
1 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Peripheral coldness
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pallor
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Intermittent claudication
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
18 / 138 (13.04%) |
45 / 692 (6.50%) |
5 / 138 (3.62%) |
occurrences all number
|
27 |
57 |
6 |
Hyperaemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Hot flush
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
8 / 692 (1.16%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
16 |
1 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
1 |
Flushing
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
8 |
2 |
Essential hypertension
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Embolism
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Cataract operation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
4 / 138 (2.90%) |
occurrences all number
|
1 |
0 |
5 |
General disorders and administration site conditions
|
|
|
|
Pyrexia
|
|
|
|
subjects affected / exposed
|
32 / 138 (23.19%) |
159 / 692 (22.98%) |
28 / 138 (20.29%) |
occurrences all number
|
45 |
258 |
49 |
Fatigue
|
|
|
|
subjects affected / exposed
|
30 / 138 (21.74%) |
115 / 692 (16.62%) |
19 / 138 (13.77%) |
occurrences all number
|
46 |
157 |
25 |
Asthenia
|
|
|
|
subjects affected / exposed
|
27 / 138 (19.57%) |
113 / 692 (16.33%) |
19 / 138 (13.77%) |
occurrences all number
|
43 |
167 |
28 |
Chest pain
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
27 / 692 (3.90%) |
7 / 138 (5.07%) |
occurrences all number
|
12 |
29 |
7 |
Infusion site erythema
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
6 |
16 |
0 |
Chills
|
|
|
|
subjects affected / exposed
|
8 / 138 (5.80%) |
40 / 692 (5.78%) |
9 / 138 (6.52%) |
occurrences all number
|
8 |
47 |
9 |
Influenza like illness
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
20 / 692 (2.89%) |
6 / 138 (4.35%) |
occurrences all number
|
24 |
45 |
9 |
Mucosal inflammation
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
25 / 692 (3.61%) |
7 / 138 (5.07%) |
occurrences all number
|
6 |
27 |
8 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
38 / 692 (5.49%) |
7 / 138 (5.07%) |
occurrences all number
|
6 |
40 |
8 |
Chest discomfort
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
10 / 692 (1.45%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
10 |
3 |
General physical health deterioration
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Hyperthermia
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
8 |
1 |
Injection site induration
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
9 |
17 |
2 |
Infusion site inflammation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Injection site pain
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
24 / 692 (3.47%) |
6 / 138 (4.35%) |
occurrences all number
|
3 |
34 |
7 |
Oedema
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
9 / 692 (1.30%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
9 |
2 |
Pain
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
8 |
2 |
Hypothermia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
7 |
0 |
Injection site discomfort
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Injection site mass
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
3 |
3 |
Malaise
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
10 / 692 (1.45%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
10 |
1 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
8 |
0 |
Administration site extravasation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
6 |
0 |
Administration site inflammation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Application site erythema
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Application site pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Catheter site thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Cyst
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Discomfort
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Facial pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Feeling abnormal
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Feeling cold
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Feeling hot
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
5 |
1 |
Feeling of body temperature change
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Granuloma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Inflammation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
6 |
1 |
Injection site erythema
|
|
|
|
subjects affected / exposed
|
10 / 138 (7.25%) |
38 / 692 (5.49%) |
9 / 138 (6.52%) |
occurrences all number
|
11 |
46 |
14 |
Infusion site haematoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Injection site inflammation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
8 / 692 (1.16%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
9 |
3 |
Injection site bruising
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
5 |
1 |
Infusion site pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Infusion site rash
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Injection site discolouration
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Injection site haematoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
5 |
0 |
Injection site hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Injection site irritation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Injection site pruritus
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Performance status decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Injection site reaction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
10 / 692 (1.45%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
13 |
1 |
Injection site swelling
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Injection site thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Injection site warmth
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Localised oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Polyp
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Puncture site erythema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Puncture site pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Unevaluable event
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Vessel puncture site haematoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Xerosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Swelling
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Injection site rash
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
8 / 692 (1.16%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
9 |
1 |
Infusion site extravasation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Axillary pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Administration site pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Catheter site haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Face oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Implant site haematoma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Haemorrhagic cyst
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Injection site oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Injection site plaque
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Thirst
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Immune system disorders
|
|
|
|
Hypogammaglobulinaemia
|
|
|
|
subjects affected / exposed
|
9 / 138 (6.52%) |
26 / 692 (3.76%) |
9 / 138 (6.52%) |
occurrences all number
|
9 |
26 |
9 |
Hypersensitivity
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
7 / 692 (1.01%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
7 |
0 |
Immune system disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Iodine allergy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Seasonal allergy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
4 |
2 |
Sarcoidosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Immunodeficiency
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Drug hypersensitivity
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
7 |
0 |
Cytokine release syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
4 |
0 |
0 |
Amenorrhoea
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Cystocele
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Dysmenorrhoea
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Erectile dysfunction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Menstrual disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Ovarian cyst
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
0 |
1 |
Pelvic discomfort
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Pelvic pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
0 |
1 |
Premature menopause
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
0 |
0 |
Pruritus genital
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Testicular oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
0 |
1 |
Testicular pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Vaginal discharge
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
0 |
1 |
Vulvovaginal erythema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
0 / 692 (0.00%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
0 |
1 |
Prostatic discomfort
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
0 / 692 (0.00%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
0 |
0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Cough
|
|
|
|
subjects affected / exposed
|
47 / 138 (34.06%) |
135 / 692 (19.51%) |
24 / 138 (17.39%) |
occurrences all number
|
72 |
185 |
37 |
Oropharyngeal pain
|
|
|
|
subjects affected / exposed
|
15 / 138 (10.87%) |
39 / 692 (5.64%) |
5 / 138 (3.62%) |
occurrences all number
|
15 |
40 |
5 |
Dysphonia
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
14 / 692 (2.02%) |
3 / 138 (2.17%) |
occurrences all number
|
7 |
18 |
4 |
Dyspnoea
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
55 / 692 (7.95%) |
11 / 138 (7.97%) |
occurrences all number
|
7 |
62 |
11 |
Rhinorrhoea
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
14 / 692 (2.02%) |
2 / 138 (1.45%) |
occurrences all number
|
6 |
14 |
2 |
Productive cough
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
25 / 692 (3.61%) |
8 / 138 (5.80%) |
occurrences all number
|
5 |
28 |
8 |
Epistaxis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
12 / 692 (1.73%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
15 |
3 |
Rhinitis allergic
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
11 / 692 (1.59%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
11 |
2 |
Asthma
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
3 |
Nasal congestion
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
8 |
2 |
Pharyngeal parasthesia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
2 |
Sleep apnoea syndrome
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Throat irritation
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
5 |
2 |
Atelectasis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Bronchial disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Bronchial hyperreactivity
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Bronchial obstruction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Bronchiectasis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Bronchitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Bronchospasm
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
7 / 692 (1.01%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
7 |
2 |
Catarrh
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
7 |
1 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Increased upper airway secretion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Laryngeal pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Larynx irritation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
4 |
2 |
Nasal pruritus
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
2 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Painful respiration
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pharyngeal inflammation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Pleuritic pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
5 |
1 |
Pulmonary fibrosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Upper respiratory tract inflammation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Upper-airway cough syndrome
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Wheezing
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
4 |
2 |
Upper airway obstruction
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tracheomalacia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Throat tightness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Sneezing
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Sinus polyp
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Sinus disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Sinus congestion
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Rhonchi
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Rhinitis atrophic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rales
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pulmonary mass
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pulmonary arterial hypertension
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pleurisy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Oropharyngeal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Obstructive airways disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Obliterative bronchiolitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Noninfective bronchitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Nasal polyps
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nasal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Laryngospasm
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hiccups
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Emphysema
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Dry throat
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
9 / 692 (1.30%) |
2 / 138 (1.45%) |
occurrences all number
|
5 |
10 |
2 |
Bronchomalacia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Asthmatic crisis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Adenoidal hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Psychiatric disorders
|
|
|
|
Depression
|
|
|
|
subjects affected / exposed
|
8 / 138 (5.80%) |
20 / 692 (2.89%) |
2 / 138 (1.45%) |
occurrences all number
|
8 |
20 |
2 |
Insomnia
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
31 / 692 (4.48%) |
5 / 138 (3.62%) |
occurrences all number
|
8 |
33 |
5 |
Sleep disorder
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
1 |
Stress
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Adjustment disorder with depressed mood
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Anxiety
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
22 / 692 (3.18%) |
9 / 138 (6.52%) |
occurrences all number
|
1 |
23 |
9 |
Anxiety disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Confusional state
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
5 |
1 |
Restlessness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Panic attack
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Mood altered
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Loss of libido
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Feeling of despair
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Depressed mood
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Delirium
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Agitation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Investigations
|
|
|
|
Blood lactate dehydrogenase increased
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
14 / 692 (2.02%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
16 |
1 |
Alanine aminitransferase increased
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
11 / 692 (1.59%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
20 |
7 |
Aspartate aminotransferase increased
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
11 / 692 (1.59%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
13 |
4 |
CD4 lymphocytes decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
3 |
3 |
Blood bilirubin increased
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
2 |
Blood pressure abnormal
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Biopsy prostate
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood alkaline phosphatase increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
8 / 692 (1.16%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
9 |
1 |
Blood creatine increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood pressure increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
4 |
1 |
Cardiac murmur
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Electrocardiogram QT prolonged
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Transaminases increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
6 |
1 |
White blood cell count increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
White blood cell count decreased
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
46 / 692 (6.65%) |
13 / 138 (9.42%) |
occurrences all number
|
19 |
72 |
21 |
Weight increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
6 |
1 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
25 / 692 (3.61%) |
4 / 138 (2.90%) |
occurrences all number
|
7 |
27 |
4 |
Transferrin saturation decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pulse abnormal
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Prostatic specific antigen increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Polymerase chain reaction positive
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Platelet count increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
14 / 138 (10.14%) |
59 / 692 (8.53%) |
10 / 138 (7.25%) |
occurrences all number
|
20 |
96 |
13 |
Oxygen saturation decrease
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Neutrophil count increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Neutrophil count decreased
|
|
|
|
subjects affected / exposed
|
28 / 138 (20.29%) |
113 / 692 (16.33%) |
29 / 138 (21.01%) |
occurrences all number
|
65 |
289 |
60 |
Lymphocyte count increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Lymphocyte count decreased
|
|
|
|
subjects affected / exposed
|
13 / 138 (9.42%) |
45 / 692 (6.50%) |
14 / 138 (10.14%) |
occurrences all number
|
17 |
80 |
23 |
Liver palpable
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Liver function test increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
International normalised ratio increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
International normalised ratio decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Immunoglobulins decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Hypophonesis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Histamine level increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hepatic enzyme increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Haemoglobin decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Gamma-glutamyltransferase increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
8 |
0 |
Eosinophil count increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Ejection fraction decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Coagulation time prolonged
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
C-reactive protein increased
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
17 / 692 (2.46%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
17 |
2 |
Body temperature increased
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Blood urea increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood sodium decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Blood potassium decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Blood phosphorus decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood magnesium decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Blood iron decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Blood immunoglobulin M decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Blood immunoglobulin G decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
5 |
0 |
Blood glucose increased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Blood folate decreased
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
12 / 692 (1.73%) |
4 / 138 (2.90%) |
occurrences all number
|
4 |
17 |
5 |
Blood cholesterol increased
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
3 |
1 |
Injury, poisoning and procedural complications
|
|
|
|
Contusion
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
4 |
6 |
0 |
Infusion related reaction
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
23 / 692 (3.32%) |
3 / 138 (2.17%) |
occurrences all number
|
4 |
24 |
3 |
Head injury
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Muscle strain
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Procedural pain
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Skin abrasion
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Administration related reaction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Animal bite
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Arthropod bite
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Dental restoration failure
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Fall
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
11 / 692 (1.59%) |
4 / 138 (2.90%) |
occurrences all number
|
1 |
12 |
4 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Joint injury
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Ligament rupture
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Ligament sprain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Limb injury
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
5 |
0 |
Muscle rupture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pelvic fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Radiation injury
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Radiation skin injury
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Thermal burn
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tooth avulsion
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Tooth fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
4 |
0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Traumatic haematoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Upper limb fracture
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Wrist fracture
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Scratch
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Spinal fracture
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Procedural site reaction
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Post-traumatic pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Medication error
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hand fracture
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Laceration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Epicondylitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Craniocerebral injury
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cardiac disorders
|
|
|
|
Tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
10 / 692 (1.45%) |
4 / 138 (2.90%) |
occurrences all number
|
0 |
10 |
4 |
Palpitations
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
9 / 692 (1.30%) |
4 / 138 (2.90%) |
occurrences all number
|
3 |
11 |
5 |
Sinus tachycardia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
4 |
0 |
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
7 / 692 (1.01%) |
4 / 138 (2.90%) |
occurrences all number
|
1 |
8 |
5 |
Aortic valve incompetence
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
4 |
1 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Bundle branch block left
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Extrasystoles
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hyperkinetic heart syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Left ventricular failure
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Mitral valve incompetence
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Supraventricular tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Vantricular arrhythmia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Sinus bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Pericardial effusion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cardiac failure chronic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Atrioventricular block complete
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
12 |
2 |
Nervous system disorders
|
|
|
|
Headache
|
|
|
|
subjects affected / exposed
|
16 / 138 (11.59%) |
68 / 692 (9.83%) |
18 / 138 (13.04%) |
occurrences all number
|
24 |
92 |
25 |
Neuropathy peripheral
|
|
|
|
subjects affected / exposed
|
8 / 138 (5.80%) |
23 / 692 (3.32%) |
7 / 138 (5.07%) |
occurrences all number
|
9 |
25 |
8 |
Dysgeusia
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
17 / 692 (2.46%) |
3 / 138 (2.17%) |
occurrences all number
|
11 |
21 |
3 |
Peripheral sensory neuropathy
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
10 / 692 (1.45%) |
3 / 138 (2.17%) |
occurrences all number
|
4 |
10 |
3 |
Presyncope
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
5 |
1 |
Amnesia
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
5 |
1 |
Sciatica
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
12 / 692 (1.73%) |
4 / 138 (2.90%) |
occurrences all number
|
3 |
14 |
5 |
Syncope
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
10 / 692 (1.45%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
10 |
2 |
Carotid arteriosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Memory impairment
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
2 |
Ageusia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Aphasia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Aphonia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Ataxia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Cerebral ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Cluster headache
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Diabetic neuropathy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Facial paralysis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
1 |
Neuromuscular pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Nystagmus
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Parkinsonism
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Parosmia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Polyneuropathy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Sensorimotor disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Vertebrobasilar insufficiency
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tremor
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
13 / 692 (1.88%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
15 |
4 |
Tension headache
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Somnolence
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
4 |
3 |
Sensory disturbance
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Seizure
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Post herpetic neuralgia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
5 |
2 |
Peripheral sensorimotor neuropathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Paraesthesia
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
29 / 692 (4.19%) |
9 / 138 (6.52%) |
occurrences all number
|
5 |
29 |
9 |
Nerve root compression
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nerve compression
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lumbar radiculopathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lethargy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
5 |
0 |
Intention tremor
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypotonia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypokinesia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hypoaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
8 |
3 |
Hypersomnia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hemiparesis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Formication
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Facial neuralgia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dysgraphia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Dysaesthesia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
3 / 138 (2.17%) |
occurrences all number
|
1 |
6 |
3 |
Dizziness
|
|
|
|
subjects affected / exposed
|
16 / 138 (11.59%) |
36 / 692 (5.20%) |
8 / 138 (5.80%) |
occurrences all number
|
21 |
42 |
8 |
Disturbance in attention
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cerebral microangiopathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Burning sensation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Balance disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Arachnoid cyst
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Anosmia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Blood and lymphatic system disorders
|
|
|
|
Neutropenia
|
|
|
|
subjects affected / exposed
|
48 / 138 (34.78%) |
226 / 692 (32.66%) |
51 / 138 (36.96%) |
occurrences all number
|
134 |
604 |
173 |
Anaemia
|
|
|
|
subjects affected / exposed
|
23 / 138 (16.67%) |
106 / 692 (15.32%) |
21 / 138 (15.22%) |
occurrences all number
|
35 |
172 |
32 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
14 / 138 (10.14%) |
52 / 692 (7.51%) |
9 / 138 (6.52%) |
occurrences all number
|
47 |
126 |
18 |
Lymphopenia
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
16 / 692 (2.31%) |
1 / 138 (0.72%) |
occurrences all number
|
13 |
34 |
1 |
Febrile neutropenia
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
15 / 692 (2.17%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
22 |
8 |
Lymphadenopathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
3 |
3 |
Agranulocytosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
1 |
3 |
Haematotoxicity
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
4 |
1 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
9 / 138 (6.52%) |
49 / 692 (7.08%) |
10 / 138 (7.25%) |
occurrences all number
|
12 |
75 |
13 |
Microcytosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Lymphocytosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Lymph node pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Iron deficiency anaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypoglobulinaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypochromic anaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eosinophilia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Ear and labyrinth disorders
|
|
|
|
Vertigo
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
18 / 692 (2.60%) |
2 / 138 (1.45%) |
occurrences all number
|
10 |
21 |
2 |
Tinnitus
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
9 / 692 (1.30%) |
2 / 138 (1.45%) |
occurrences all number
|
6 |
10 |
2 |
Ear pain
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
11 / 692 (1.59%) |
2 / 138 (1.45%) |
occurrences all number
|
4 |
12 |
2 |
Deafness unilateral
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
3 |
2 |
Deafness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Hypoacusis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
1 |
Tympanic membrane disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Vestibular disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Middle ear inflammation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eye disorders
|
|
|
|
Eye pain
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
4 |
6 |
0 |
Dry eye
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Cataract
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
5 |
2 |
Vision blurred
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
1 |
Visual impairment
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
6 |
1 |
Chalazion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Diabetic retinopathy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Eye inflammation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Eye irritation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Eye pruritus
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Eyelid oedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Noninfective conjunctivitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Ocular hyperaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Periorbital oedema
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Visual acuity reduced
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Vitreous floaters
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Eyelid swelling
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lacrimation increased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Eye discharge
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Entropion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Conjunctivitis allergic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Conjunctival hyperaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrointestinal disorders
|
|
|
|
Nausea
|
|
|
|
subjects affected / exposed
|
45 / 138 (32.61%) |
199 / 692 (28.76%) |
37 / 138 (26.81%) |
occurrences all number
|
63 |
312 |
65 |
Diarrhoea
|
|
|
|
subjects affected / exposed
|
35 / 138 (25.36%) |
143 / 692 (20.66%) |
28 / 138 (20.29%) |
occurrences all number
|
50 |
211 |
36 |
Vomiting
|
|
|
|
subjects affected / exposed
|
23 / 138 (16.67%) |
96 / 692 (13.87%) |
15 / 138 (10.87%) |
occurrences all number
|
32 |
160 |
22 |
Constipation
|
|
|
|
subjects affected / exposed
|
21 / 138 (15.22%) |
98 / 692 (14.16%) |
15 / 138 (10.87%) |
occurrences all number
|
26 |
129 |
22 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
13 / 138 (9.42%) |
57 / 692 (8.24%) |
13 / 138 (9.42%) |
occurrences all number
|
15 |
74 |
23 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
39 / 692 (5.64%) |
4 / 138 (2.90%) |
occurrences all number
|
16 |
49 |
5 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
20 / 692 (2.89%) |
7 / 138 (5.07%) |
occurrences all number
|
13 |
24 |
9 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
10 / 138 (7.25%) |
26 / 692 (3.76%) |
7 / 138 (5.07%) |
occurrences all number
|
10 |
27 |
7 |
Stomatitis
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
17 / 692 (2.46%) |
3 / 138 (2.17%) |
occurrences all number
|
5 |
18 |
4 |
Toothache
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
9 / 692 (1.30%) |
2 / 138 (1.45%) |
occurrences all number
|
5 |
9 |
2 |
Aphthous ulcer
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
6 / 692 (0.87%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
6 |
3 |
Colitis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
5 |
8 |
0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
12 / 692 (1.73%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
12 |
3 |
Mouth ulceration
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
12 / 692 (1.73%) |
3 / 138 (2.17%) |
occurrences all number
|
4 |
15 |
4 |
Oral pain
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
15 / 692 (2.17%) |
5 / 138 (3.62%) |
occurrences all number
|
3 |
16 |
5 |
Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
5 |
2 |
Abdominal distension
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
8 |
1 |
Enterocolitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Gastrointestinal disorder
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
5 |
2 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
4 |
1 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Irritable bowel syndrome
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Tongue ulceration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
4 |
2 |
Tooth disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
2 |
Abdominal tenderness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Crohn's disease
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
2 |
Diverticulum intestinal
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Dry mouth
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
10 / 692 (1.45%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
10 |
1 |
Dysphagia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
10 / 692 (1.45%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
10 |
1 |
Eructation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Faecaloma
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Faeces soft
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Flatulence
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
7 |
1 |
Gastritis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
12 / 692 (1.73%) |
6 / 138 (4.35%) |
occurrences all number
|
1 |
12 |
6 |
Gastrointestinal hypomotility
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Gastrointestinal sounds abnormal
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Gingival bleeding
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Haematochezia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Haemorrhoidal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
4 |
1 |
Haemorrhoids thrombosed
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Ileal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Melaena
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Noninfective gingivitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Odynophagia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
7 / 692 (1.01%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
10 |
5 |
Pancreatic cyst
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Proctalgia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Rectal polyp
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Sensitivity of teeth
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tongue coated
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tongue geographic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tooth loss
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Ascites
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
4 |
0 |
Anal fissure
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Paraesthesia oral
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Lip ulceration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Anal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Change in bowel habit
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Chronic gastritis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tooth development disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Salivary hypersecretion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Perianal erythema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pancreatic duct dilatation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Oral disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Large intestinal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrointestinal toxicity
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrointestinal inflammation
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Food poisoning
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Epigastric discomfort
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dyschezia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Defaecation urgency
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Rash
|
|
|
|
subjects affected / exposed
|
19 / 138 (13.77%) |
76 / 692 (10.98%) |
18 / 138 (13.04%) |
occurrences all number
|
24 |
97 |
23 |
Pruritus
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
51 / 692 (7.37%) |
9 / 138 (6.52%) |
occurrences all number
|
14 |
61 |
12 |
Alopecia
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
23 / 692 (3.32%) |
6 / 138 (4.35%) |
occurrences all number
|
6 |
26 |
7 |
Erythema
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
29 / 692 (4.19%) |
6 / 138 (4.35%) |
occurrences all number
|
7 |
39 |
7 |
Eczema
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
12 / 692 (1.73%) |
4 / 138 (2.90%) |
occurrences all number
|
3 |
14 |
4 |
Hyperhidrosis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
15 / 692 (2.17%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
15 |
2 |
Night sweats
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
19 / 692 (2.75%) |
3 / 138 (2.17%) |
occurrences all number
|
5 |
22 |
4 |
Skin lesion
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
19 / 692 (2.75%) |
7 / 138 (5.07%) |
occurrences all number
|
3 |
22 |
8 |
Urticaria
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
15 / 692 (2.17%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
20 |
7 |
Actinic keratosis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
10 / 692 (1.45%) |
3 / 138 (2.17%) |
occurrences all number
|
2 |
11 |
3 |
Hyperkeratosis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
8 |
2 |
Psoriasis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Purpura
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
4 |
2 |
Rash erythematous
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
7 |
1 |
Angioedema
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Dermatitis bullous
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
4 |
4 |
0 |
Granulomatous rosacea
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Neurodermatitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Panniculitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pityriasis rosea
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Rash follicular
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Rash macular
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Rosacea
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Seborrhoeic dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
5 |
3 |
Skin exfoliation
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Skin reaction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
6 |
2 |
Swelling face
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Stasis dermatitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
3 |
1 |
Skin ulcer
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
3 / 138 (2.17%) |
occurrences all number
|
1 |
4 |
3 |
Skin swelling
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Skin mass
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Skin disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Sebaceous hyperplasia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rash pruritic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
3 |
0 |
Rash papular
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
8 |
1 |
Rash maculo-papular
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
10 |
3 |
Rash generalised
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pruritus generalised
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
1 |
Pruritus allergic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Prurigo
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Perioral dermatitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pain of skin
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nail discolouration
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Macule
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Intertrigo
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Hypertrichiosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Exfoliative rash
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Erythema nodosum
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Erythema multiforme
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Eczema nummular
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Ecchymosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Dry skin
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
10 / 692 (1.45%) |
3 / 138 (2.17%) |
occurrences all number
|
5 |
11 |
3 |
Drug eruption
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
5 |
0 |
Dermatomyositis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Dermatitis atopic
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Dermatitis allergic
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
2 |
Dermatitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
5 |
2 |
Dermal cyst
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Blood blister
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Acne
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Renal and urinary disorders
|
|
|
|
Pollakiuria
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
9 / 692 (1.30%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
10 |
1 |
Dysuria
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
13 / 692 (1.88%) |
6 / 138 (4.35%) |
occurrences all number
|
2 |
14 |
6 |
Haematuria
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
1 |
Renal failure
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
9 |
2 |
Strangury
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
3 |
2 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Bladder disorder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Bladder hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Chronic kidney disease
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hypertonic bladder
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Nephroangiosclerosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
3 / 138 (2.17%) |
occurrences all number
|
1 |
6 |
3 |
Nocturia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Renal colic
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Urethral haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Urinary incontinence
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
7 |
3 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Urinary tract pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
5 |
1 |
Renal pain
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Renal cyst
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Renal atrophy
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Polyuria
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Micturition urgency
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Leukocyturia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cystitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Acute kidney injury
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Myalgia
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
16 / 692 (2.31%) |
5 / 138 (3.62%) |
occurrences all number
|
5 |
17 |
5 |
Osteoporosis
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
8 |
1 |
Spinal osteoarthritis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
4 |
1 |
Chondrocalcinosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Exostosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Limb mass
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Muscle tightness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Musculoskeletal discomfort
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Osteopenia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Periostitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Sjogren's syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Spinal column stenosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Spinal pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
4 |
0 |
Tenosynovitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Tendonitis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
4 |
1 |
Tendon disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Synovial cyst
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Spondylitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Periarthritis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Polyarthritis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pain in jaw
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
2 |
2 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
10 / 138 (7.25%) |
43 / 692 (6.21%) |
10 / 138 (7.25%) |
occurrences all number
|
10 |
46 |
11 |
Osteochondrosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
14 / 692 (2.02%) |
5 / 138 (3.62%) |
occurrences all number
|
3 |
15 |
5 |
Osteitis deformans
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
11 / 692 (1.59%) |
3 / 138 (2.17%) |
occurrences all number
|
5 |
12 |
3 |
Myofascial pain syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Musculoskeletal stiffness
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Musculoskeletal pain
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
22 / 692 (3.18%) |
6 / 138 (4.35%) |
occurrences all number
|
5 |
22 |
6 |
Musculoskeletal chest pain
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
5 |
2 |
Muscle spasms
|
|
|
|
subjects affected / exposed
|
10 / 138 (7.25%) |
25 / 692 (3.61%) |
5 / 138 (3.62%) |
occurrences all number
|
10 |
28 |
7 |
Muscle fatigue
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Muscle contracture
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Mobility decreased
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Joint swelling
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
8 |
3 |
Limb discomfort
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Joint stiffness
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Groin pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
2 |
Foot deformity
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Flank pain
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
6 |
1 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Bone pain
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
17 / 692 (2.46%) |
3 / 138 (2.17%) |
occurrences all number
|
2 |
17 |
3 |
Back pain
|
|
|
|
subjects affected / exposed
|
14 / 138 (10.14%) |
62 / 692 (8.96%) |
13 / 138 (9.42%) |
occurrences all number
|
16 |
72 |
19 |
Axillary mass
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Arthritis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
5 |
2 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
15 / 138 (10.87%) |
52 / 692 (7.51%) |
14 / 138 (10.14%) |
occurrences all number
|
22 |
68 |
23 |
Infections and infestations
|
|
|
|
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
29 / 138 (21.01%) |
72 / 692 (10.40%) |
24 / 138 (17.39%) |
occurrences all number
|
55 |
120 |
36 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
24 / 138 (17.39%) |
78 / 692 (11.27%) |
21 / 138 (15.22%) |
occurrences all number
|
55 |
126 |
27 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
24 / 138 (17.39%) |
63 / 692 (9.10%) |
20 / 138 (14.49%) |
occurrences all number
|
36 |
85 |
26 |
Influenza
|
|
|
|
subjects affected / exposed
|
20 / 138 (14.49%) |
56 / 692 (8.09%) |
14 / 138 (10.14%) |
occurrences all number
|
23 |
65 |
18 |
Rhinitis
|
|
|
|
subjects affected / exposed
|
19 / 138 (13.77%) |
42 / 692 (6.07%) |
9 / 138 (6.52%) |
occurrences all number
|
21 |
46 |
9 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
17 / 138 (12.32%) |
46 / 692 (6.65%) |
9 / 138 (6.52%) |
occurrences all number
|
37 |
76 |
14 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
17 / 138 (12.32%) |
44 / 692 (6.36%) |
10 / 138 (7.25%) |
occurrences all number
|
22 |
55 |
13 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
16 / 138 (11.59%) |
46 / 692 (6.65%) |
12 / 138 (8.70%) |
occurrences all number
|
18 |
50 |
12 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
14 / 138 (10.14%) |
45 / 692 (6.50%) |
16 / 138 (11.59%) |
occurrences all number
|
27 |
67 |
21 |
Conjunctivitis
|
|
|
|
subjects affected / exposed
|
12 / 138 (8.70%) |
24 / 692 (3.47%) |
4 / 138 (2.90%) |
occurrences all number
|
14 |
27 |
5 |
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
11 / 138 (7.97%) |
55 / 692 (7.95%) |
14 / 138 (10.14%) |
occurrences all number
|
14 |
73 |
22 |
Lung infection
|
|
|
|
subjects affected / exposed
|
10 / 138 (7.25%) |
24 / 692 (3.47%) |
5 / 138 (3.62%) |
occurrences all number
|
15 |
32 |
5 |
Oral herpes
|
|
|
|
subjects affected / exposed
|
9 / 138 (6.52%) |
25 / 692 (3.61%) |
4 / 138 (2.90%) |
occurrences all number
|
17 |
35 |
5 |
Viral infection
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
11 / 692 (1.59%) |
2 / 138 (1.45%) |
occurrences all number
|
8 |
12 |
2 |
Acute sinusitis
|
|
|
|
subjects affected / exposed
|
5 / 138 (3.62%) |
7 / 692 (1.01%) |
1 / 138 (0.72%) |
occurrences all number
|
6 |
7 |
1 |
Cystitis
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
4 |
6 |
0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
24 / 692 (3.47%) |
10 / 138 (7.25%) |
occurrences all number
|
5 |
36 |
19 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
4 / 138 (2.90%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
4 |
6 |
1 |
Candida infection
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
5 |
0 |
Ear infection
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
14 / 692 (2.02%) |
4 / 138 (2.90%) |
occurrences all number
|
4 |
17 |
4 |
Oral candidiasis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
14 / 692 (2.02%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
15 |
4 |
Pharyngitis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
9 / 692 (1.30%) |
3 / 138 (2.17%) |
occurrences all number
|
4 |
13 |
6 |
Pulpitis dental
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
3 / 138 (2.17%) |
occurrences all number
|
0 |
6 |
3 |
Tonsillitis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
6 |
3 |
Tracheitis
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
8 / 692 (1.16%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
8 |
3 |
Viral upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
7 / 692 (1.01%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
7 |
0 |
Gastroenteritis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
11 / 692 (1.59%) |
7 / 138 (5.07%) |
occurrences all number
|
2 |
12 |
7 |
Gastrointestinal infection
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
3 |
1 |
Gingivitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
3 |
6 |
2 |
Herpes simplex
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
4 |
1 |
Hordeolum
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Laryngitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
4 |
0 |
Onychomycosis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
2 |
Oral fungal infection
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
6 |
2 |
Oral infection
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Respiratory tract infection viral
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
4 |
0 |
Subcutaneous abscess
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
9 |
6 |
Tooth abscess
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
5 |
1 |
Vaginal infection
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
4 |
1 |
Viral pharyngitis
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Anal abscess
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Angular cheilitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Arthritis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Bacterial infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Blastocystis infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Bartholinitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Body tinea
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Campylobacter colitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Campylobacter gastroenteritis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Campylobacter infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
9 |
2 |
Chlamydial infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Cytomegalovirus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Dacryocanaliculitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Device related sepsis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Diarrhoea infectious
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Epstein-Barr virus infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
4 |
2 |
Escherichia urinary tract infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
8 |
4 |
Eye infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
3 |
1 |
Eyelid infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Folliculitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
12 |
5 |
Fungal infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
6 |
1 |
Fungal skin infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
5 |
3 |
Furuncle
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
7 |
4 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Genital herpes simplex
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Haemophilus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Helicobacter gastritis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Hepatitis B
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hepatitis viral
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Herpes virus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
2 |
Infected bite
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
4 |
1 |
Infectious colitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Injection site cellulitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Labyrinthitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Lip infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lower respiratory tract infection viral
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Lymphangitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Mucosal infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Nail infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Otitis externa
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
2 |
Otitis media
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Parainfluenzae virus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Periorbital infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pertussis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pharyngotonsillitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
2 |
1 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Pneumonia fungal
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Proteus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
3 |
0 |
Rash pustular
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
5 |
1 |
Respiratory syncytial virus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Skin infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
3 / 138 (2.17%) |
occurrences all number
|
1 |
4 |
3 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
3 |
0 |
Tinea pedis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Tooth infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
5 / 692 (0.72%) |
2 / 138 (1.45%) |
occurrences all number
|
2 |
6 |
2 |
Trichomoniasis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Varicella zoster virus infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
2 |
0 |
Viral parotitis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Vulvitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Vulvovaginal mycotic infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
3 |
5 |
2 |
Wound infection
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
3 / 692 (0.43%) |
2 / 138 (1.45%) |
occurrences all number
|
1 |
3 |
2 |
Bacteuria
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Ureaplasma infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Sinusitis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Superinfection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Sepsis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Rectal abscess
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pyoderma
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Puncture site abscess
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pseudomonas infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Pseudomembranous colitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Paronychia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
3 / 692 (0.43%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
6 |
0 |
Orchitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Oesophageal candidiasis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Nasal herpes
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Meningitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Herpes zoster oticus
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Herpes zoster infection neurological
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hepatic infection fungal
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastrointestinal fungal infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Gastroenteritis salmonella
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Cystitis Escherichia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Balanitis candida
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Arthritis infective
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Application site cellulitis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Abscess oral
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Abdominal infection
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Metabolism and nutrition disorders
|
|
|
|
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
3 / 138 (2.17%) |
7 / 692 (1.01%) |
3 / 138 (2.17%) |
occurrences all number
|
3 |
7 |
3 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
0 / 138 (0.00%) |
occurrences all number
|
3 |
8 |
0 |
Hypophosphataemia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
7 / 692 (1.01%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
9 |
0 |
Dyslipidaemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
4 / 692 (0.58%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
5 |
0 |
Increased appetite
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Vitamin D deficiency
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
4 / 692 (0.58%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
4 |
1 |
Vitamin B12 deficiency
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Type 2 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Tumour lysis syndrome
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Tetany
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Obesity
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
2 |
1 |
Metabolic disorder
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
1 |
1 |
Malnutrition
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Lactose intolerance
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
2 |
0 |
Iron deficiency
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
2 |
3 |
0 |
Hypovitaminosis
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypouricaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypoproteinaemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hypophagia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
0 |
9 |
1 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
22 / 692 (3.18%) |
1 / 138 (0.72%) |
occurrences all number
|
10 |
31 |
1 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
7 |
0 |
Hypoalbminaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
5 / 692 (0.72%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
5 |
0 |
Hyperuricaemia
|
|
|
|
subjects affected / exposed
|
6 / 138 (4.35%) |
10 / 692 (1.45%) |
3 / 138 (2.17%) |
occurrences all number
|
9 |
13 |
3 |
Hypertriglyceridaemia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
3 / 692 (0.43%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
3 |
1 |
Hyperphosphataemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Hypernatraemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
2 / 692 (0.29%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
2 |
0 |
Hyperlipidaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
8 / 692 (1.16%) |
2 / 138 (1.45%) |
occurrences all number
|
5 |
11 |
2 |
Hypercholesterolaemia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
4 / 692 (0.58%) |
2 / 138 (1.45%) |
occurrences all number
|
0 |
4 |
2 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
1 |
6 |
1 |
Gout
|
|
|
|
subjects affected / exposed
|
2 / 138 (1.45%) |
6 / 692 (0.87%) |
1 / 138 (0.72%) |
occurrences all number
|
2 |
6 |
1 |
Folate deficiency
|
|
|
|
subjects affected / exposed
|
1 / 138 (0.72%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
1 |
1 |
0 |
Fluid retention
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Fluid overload
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
7 / 138 (5.07%) |
48 / 692 (6.94%) |
7 / 138 (5.07%) |
occurrences all number
|
9 |
56 |
9 |
Cachexia
|
|
|
|
subjects affected / exposed
|
0 / 138 (0.00%) |
1 / 692 (0.14%) |
0 / 138 (0.00%) |
occurrences all number
|
0 |
1 |
0 |