Serious adverse events
|
MPA plus standard@CNI |
Everolimus plus@reduced CNI |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
613 / 1012 (60.57%) |
593 / 1014 (58.48%) |
number of deaths (all causes)
|
29 |
20 |
number of deaths resulting from adverse events
|
0 |
0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Adenocarcinoma gastric
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
10 / 1014 (0.99%) |
occurrences causally related to treatment / all
|
4 / 5 |
8 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign gastrointestinal neoplasm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of thyroid gland
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchioloalveolar carcinoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral haemangioma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epstein-Barr virus associated lymphoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Leydig cell tumour of the testis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lipoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoproliferative disorder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
1 / 1 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura metastatic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to bone
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to lymph nodes
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to spine
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoclonal gammopathy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary tumour of renal pelvis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasmacytoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia vera
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post transplant lymphoproliferative disorder
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland cancer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
8 / 1014 (0.79%) |
occurrences causally related to treatment / all
|
5 / 5 |
5 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
4 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Testicular neoplasm
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tumour of ampulla of Vater
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic perforation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial thrombosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Artery dissection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
12 / 1012 (1.19%) |
20 / 1014 (1.97%) |
occurrences causally related to treatment / all
|
2 / 14 |
9 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
8 / 1012 (0.79%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
21 / 1012 (2.08%) |
34 / 1014 (3.35%) |
occurrences causally related to treatment / all
|
4 / 22 |
18 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphorrhoea
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchidectomy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
Cephalhaematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chills
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait inability
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthermia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ill-defined disorder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
10 / 1014 (0.99%) |
occurrences causally related to treatment / all
|
1 / 1 |
10 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site discomfort
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site inflammation
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microlithiasis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
7 / 1014 (0.69%) |
occurrences causally related to treatment / all
|
0 / 4 |
5 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
36 / 1012 (3.56%) |
35 / 1014 (3.45%) |
occurrences causally related to treatment / all
|
13 / 40 |
16 / 45 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Suprapubic pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic allograft nephropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immunosuppression
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney transplant rejection
|
|
|
subjects affected / exposed
|
17 / 1012 (1.68%) |
18 / 1014 (1.78%) |
occurrences causally related to treatment / all
|
9 / 19 |
8 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal transplant failure
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
subjects affected / exposed
|
25 / 1012 (2.47%) |
45 / 1014 (4.44%) |
occurrences causally related to treatment / all
|
7 / 27 |
16 / 49 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Loss of personal independence in daily activities
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Walking disability
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Acquired hydrocele
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometriosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erectile dysfunction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst ruptured
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
3 / 4 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular oedema
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthmatic crisis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
8 / 1014 (0.79%) |
occurrences causally related to treatment / all
|
1 / 8 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperventilation
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infiltration
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleuritic pain
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Productive cough
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
17 / 1014 (1.68%) |
occurrences causally related to treatment / all
|
1 / 6 |
6 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aggression
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic stress disorder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stone
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary dilatation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular injury
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perforation bile duct
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biopsy kidney
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine increased
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine abnormal
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
36 / 1012 (3.56%) |
50 / 1014 (4.93%) |
occurrences causally related to treatment / all
|
6 / 44 |
18 / 63 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood phosphorus decreased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood urea increased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheterisation cardiac
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction abnormal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram T wave inversion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haptoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immunosuppressant drug level increased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammatory marker increased
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Norovirus test positive
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Occult blood positive
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyomavirus test positive
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urine output decreased
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Accidental overdose
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaesthetic complication
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aponeurosis contusion
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula aneurysm
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site complication
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplant surgery
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
subjects affected / exposed
|
28 / 1012 (2.77%) |
34 / 1014 (3.35%) |
occurrences causally related to treatment / all
|
3 / 32 |
9 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary bypass stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delayed graft function
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
7 / 1014 (0.69%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft complication
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft loss
|
|
|
subjects affected / exposed
|
12 / 1012 (1.19%) |
16 / 1014 (1.58%) |
occurrences causally related to treatment / all
|
2 / 12 |
3 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site complication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
8 / 1014 (0.79%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle strain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal injury
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial reocclusion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural discharge
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural persistent drain fluid
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural urine leak
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative fever
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal lymphocele
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal transplant torsion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scar
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scrotal haematoma
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt aneurysm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt stenosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
3 / 4 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant dysfunction
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
7 / 1014 (0.69%) |
occurrences causally related to treatment / all
|
2 / 8 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant failure
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplantation complication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric anastomosis complication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary anastomotic leak
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaccination complication
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound decomposition
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
10 / 1014 (0.99%) |
occurrences causally related to treatment / all
|
0 / 3 |
7 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound secretion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital cystic kidney disease
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital megaureter
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheo-oesophageal fistula
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
12 / 1012 (1.19%) |
12 / 1014 (1.18%) |
occurrences causally related to treatment / all
|
2 / 15 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac dysfunction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
0 / 11 |
1 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiorenal syndrome
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis constrictive
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ataxia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lesion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
3 / 7 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemic seizure
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotonia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelitis transverse
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurotoxicity
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transverse sinus thrombosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tremor
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual field defect
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Agranulocytosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
14 / 1014 (1.38%) |
occurrences causally related to treatment / all
|
2 / 9 |
6 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical haemolytic uraemic syndrome
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
3 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Granulocytopenia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolysis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic uraemic syndrome
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
12 / 1012 (1.19%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
10 / 14 |
5 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphatic obstruction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphopenia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
4 / 6 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sickle cell anaemia with crisis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenomegaly
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic microangiopathy
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
8 / 1014 (0.79%) |
occurrences causally related to treatment / all
|
2 / 3 |
6 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Mastoid effusion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tinnitus
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal hernia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
14 / 1012 (1.38%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
5 / 18 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal polyp
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anogenital dysplasia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Barrett's oesophagus
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
55 / 1012 (5.43%) |
27 / 1014 (2.66%) |
occurrences causally related to treatment / all
|
32 / 60 |
9 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encapsulating peritoneal sclerosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal fistula
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mouth ulceration
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
9 / 1012 (0.89%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
3 / 11 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal achalasia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retching
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland enlargement
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus of small bowel
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
13 / 1012 (1.28%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
5 / 18 |
3 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Blister
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Capillaritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis allergic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperhidrosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peau d'orange
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin oedema
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
37 / 1012 (3.66%) |
46 / 1014 (4.54%) |
occurrences causally related to treatment / all
|
12 / 47 |
10 / 50 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anuria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neck obstruction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder perforation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urinary
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dysuria
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Focal segmental glomerulosclerosis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis membranoproliferative
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis membranous
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glycosuria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
14 / 1012 (1.38%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
0 / 6 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydroureter
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertonic bladder
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IgM nephropathy
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic nephropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocyturia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesangioproliferative glomerulonephritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive nephropathy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvi-ureteric obstruction
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric collection
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 5 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pollakiuria
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
15 / 1014 (1.48%) |
occurrences causally related to treatment / all
|
0 / 4 |
10 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelocaliectasis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery dissection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery thrombosis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cortical necrosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst ruptured
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
25 / 1012 (2.47%) |
23 / 1014 (2.27%) |
occurrences causally related to treatment / all
|
7 / 26 |
11 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal ischaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal necrosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular atrophy
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 5 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric dilatation
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urge incontinence
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary fistula
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
0 / 1 |
3 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
8 / 1012 (0.79%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinoma
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vesicoureteric reflux
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Goitre
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism tertiary
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc space narrowing
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia intercostal
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubic pain
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sacroiliitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovial cyst
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendonitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Actinomycosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenoviral haemorrhagic cystitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenovirus infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
2 / 2 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asymptomatic bacteriuria
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
BK virus infection
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
3 / 5 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial diarrhoea
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial prostatitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteriuria
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister infected
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Candiduria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
1 / 6 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest wall abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic sinusitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic tonsillitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corona virus infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cryptococcosis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis viral
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus colitis
|
|
|
subjects affected / exposed
|
9 / 1012 (0.89%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
5 / 9 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus enteritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus gastroenteritis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus gastrointestinal infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus hepatitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
subjects affected / exposed
|
48 / 1012 (4.74%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
40 / 55 |
6 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatophytosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis viral
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
4 / 9 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal sepsis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
23 / 1012 (2.27%) |
18 / 1014 (1.78%) |
occurrences causally related to treatment / all
|
8 / 25 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis cryptosporidial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
HIV infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis E
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis viral
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes simplex
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes simplex pneumonia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
1 / 4 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal gangrene
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected lymphocele
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
0 / 1 |
5 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site cellulitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device site infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis cryptococcal
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenic sepsis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nocardiosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral herpes
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
5 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
1 / 2 |
4 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parvovirus B19 infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric abscess
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngotonsillitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
2 / 3 |
6 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia
|
|
|
subjects affected / exposed
|
36 / 1012 (3.56%) |
55 / 1014 (5.42%) |
occurrences causally related to treatment / all
|
18 / 41 |
31 / 63 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia cryptococcal
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia cytomegaloviral
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pneumonia fungal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyomavirus-associated nephropathy
|
|
|
subjects affected / exposed
|
10 / 1012 (0.99%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
10 / 10 |
4 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
33 / 1012 (3.26%) |
24 / 1014 (2.37%) |
occurrences causally related to treatment / all
|
15 / 40 |
15 / 30 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
13 / 1012 (1.28%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
8 / 19 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyuria
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst infection
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal graft infection
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
2 / 5 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Respiratory tract infection fungal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection viral
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinitis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinovirus infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
7 / 1012 (0.69%) |
20 / 1014 (1.97%) |
occurrences causally related to treatment / all
|
4 / 7 |
9 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Septic shock
|
|
|
subjects affected / exposed
|
8 / 1012 (0.79%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
3 / 9 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis fungal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic candida
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant abscess
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis gastrointestinal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
3 / 5 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
93 / 1012 (9.19%) |
78 / 1014 (7.69%) |
occurrences causally related to treatment / all
|
49 / 124 |
37 / 110 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
4 / 1014 (0.39%) |
occurrences causally related to treatment / all
|
1 / 1 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection fungal
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
23 / 1012 (2.27%) |
23 / 1014 (2.27%) |
occurrences causally related to treatment / all
|
14 / 28 |
9 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Varicella
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral diarrhoea
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral myocarditis
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulvovaginal mycotic infection
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound abscess
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
1 / 4 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Cachexia
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calciphylaxis
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
11 / 1012 (1.09%) |
6 / 1014 (0.59%) |
occurrences causally related to treatment / all
|
2 / 11 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
10 / 1012 (0.99%) |
9 / 1014 (0.89%) |
occurrences causally related to treatment / all
|
5 / 10 |
6 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 1012 (0.20%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
3 / 1012 (0.30%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
0 / 3 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
6 / 1012 (0.59%) |
5 / 1014 (0.49%) |
occurrences causally related to treatment / all
|
4 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
10 / 1012 (0.99%) |
11 / 1014 (1.08%) |
occurrences causally related to treatment / all
|
2 / 11 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperlipidaemia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertriglyceridaemia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
2 / 1014 (0.20%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
0 / 1012 (0.00%) |
3 / 1014 (0.30%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
5 / 1012 (0.49%) |
1 / 1014 (0.10%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
4 / 1012 (0.40%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1012 (0.10%) |
0 / 1014 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |