Serious adverse events
|
Belatacept MI |
Belatacept LI |
Cyclosporin A |
Total subjects affected by serious adverse events
|
|
|
|
subjects affected / exposed
|
162 / 183 (88.52%) |
157 / 177 (88.70%) |
152 / 179 (84.92%) |
number of deaths (all causes)
|
35 |
35 |
29 |
number of deaths resulting from adverse events
|
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
|
Basal cell carcinoma
|
|
|
|
subjects affected / exposed
|
9 / 183 (4.92%) |
6 / 177 (3.39%) |
12 / 179 (6.70%) |
occurrences causally related to treatment / all
|
8 / 16 |
10 / 11 |
7 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Squamous cell carcinoma of skin
|
|
|
|
subjects affected / exposed
|
8 / 183 (4.37%) |
6 / 177 (3.39%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
7 / 14 |
6 / 8 |
13 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
4 / 177 (2.26%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bowen's disease
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
5 / 5 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kaposi's sarcoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Squamous cell carcinoma
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Post transplant lymphoproliferative disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
3 / 177 (1.69%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
Adenocarcinoma of colon
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
Renal cell carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Adenocarcinoma gastric
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Cholangiocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Colon cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diffuse large B-cell lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Epiglottic carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Intraductal proliferative breast lesion
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lipoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Lung cancer metastatic
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Lymphoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Malignant melanoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
Malignant pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Pancreatic carcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pituitary tumour benign
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pleural mesothelioma malignant
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic adenoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
|
Lymphocele
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
5 / 177 (2.82%) |
11 / 179 (6.15%) |
occurrences causally related to treatment / all
|
1 / 3 |
3 / 7 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
|
subjects affected / exposed
|
7 / 183 (3.83%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 5 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertension
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
5 / 177 (2.82%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypotension
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematoma
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
3 / 177 (1.69%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
3 / 177 (1.69%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aneurysm ruptured
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Angiopathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Aortic dissection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Aortic stenosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic infarction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Lymphoedema
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular stenosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous stenosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
|
Pyrexia
|
|
|
|
subjects affected / exposed
|
17 / 183 (9.29%) |
10 / 177 (5.65%) |
12 / 179 (6.70%) |
occurrences causally related to treatment / all
|
2 / 19 |
3 / 16 |
4 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chest pain
|
|
|
|
subjects affected / exposed
|
5 / 183 (2.73%) |
3 / 177 (1.69%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sudden death
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 0 |
Adverse drug reaction
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhagic cyst
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Malaise
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Multi -organ failure
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Oedema
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthenia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cyst
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Death
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Device malfunction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Extravasation
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fatigue
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza like illness
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
|
Benign prostatic hyperplasia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acquired hydrocele
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Priapism
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatic obstruction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prostatism
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectocele
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Scrotal oedema
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Testicular swelling
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uterine malposition
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
|
Dyspnoea
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
5 / 179 (2.79%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Pulmonary oedema
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
3 / 177 (1.69%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 3 |
2 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
Pleural effusion
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cough
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
Chronic obstructive pulmonary disease
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Dyspnoea exertional
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspiration
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asthma
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchial secretion retention
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspnoea paroxysmal nocturnal
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiccups
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mediastinal disorder
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Organising pneumonia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Orthopnoea
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory arrest
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vocal cord disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
|
Confusional state
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Acute psychosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Suicide attempt
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Investigations
|
|
|
|
Blood creatinine increased
|
|
|
|
subjects affected / exposed
|
14 / 183 (7.65%) |
11 / 177 (6.21%) |
17 / 179 (9.50%) |
occurrences causally related to treatment / all
|
2 / 14 |
1 / 14 |
6 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood creatine increased
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight decreased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
White blood cell count decreased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Alanine aminotransferase increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Antibody test positive
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood glucose abnormal
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
C-reactive protein increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcus test positive
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia test positive
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gamma-glutamyltransferase increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatic enzymes increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Platelet count decreased
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyomavirus test positive
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Weight increased
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
White blood cells urine positive
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
|
Transplant dysfunction
|
|
|
|
subjects affected / exposed
|
9 / 183 (4.92%) |
6 / 177 (3.39%) |
11 / 179 (6.15%) |
occurrences causally related to treatment / all
|
0 / 9 |
1 / 6 |
3 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
8 / 177 (4.52%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
1 / 4 |
2 / 10 |
2 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Graft loss
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
7 / 177 (3.95%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
3 / 4 |
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Chronic allograft nephropathy
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
5 / 179 (2.79%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
3 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
5 / 177 (2.82%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
3 / 177 (1.69%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound evisceration
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Graft complication
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Overdose
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula aneurysm
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Limb injury
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
3 / 177 (1.69%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural urine leak
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal transplant failure
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Shunt occlusion
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
4 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fall
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incorrect dose administered
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Seroma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transplant failure
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic complication
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anastomotic haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriovenous fistula occlusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cataract operation complication
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Complications of transplant surgery
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Head injury
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Hip fracture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site complication
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kidney rupture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perinephric collection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Wound
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
|
Hydrocele
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
|
Atrial fibrillation
|
|
|
|
subjects affected / exposed
|
9 / 183 (4.92%) |
11 / 177 (6.21%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 11 |
1 / 14 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
|
subjects affected / exposed
|
10 / 183 (5.46%) |
5 / 177 (2.82%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
Myocardial infarction
|
|
|
|
subjects affected / exposed
|
7 / 183 (3.83%) |
3 / 177 (1.69%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
Cardiac failure
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
3 / 177 (1.69%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Acute myocardial infarction
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Angina pectoris
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
Acute coronary syndrome
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
Arrhythmia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mitral valve stenosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arrhythmia supraventricular
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cardiovascular disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coronary artery stenosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Left ventricular dysfunction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Supraventricular tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tachyarrhythmia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
|
Cerebrovascular accident
|
|
|
|
subjects affected / exposed
|
6 / 183 (3.28%) |
1 / 177 (0.56%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
Convulsion
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ischaemic stroke
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Haemorrhage intracranial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neurotoxicity
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Brain mass
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebellar syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cerebral haematoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Dementia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dizziness
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalitis toxic
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mononeuropathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Optic neuritis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sciatica
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
|
Anaemia
|
|
|
|
subjects affected / exposed
|
11 / 183 (6.01%) |
9 / 177 (5.08%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
1 / 11 |
2 / 9 |
4 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
|
subjects affected / exposed
|
8 / 183 (4.37%) |
2 / 177 (1.13%) |
5 / 179 (2.79%) |
occurrences causally related to treatment / all
|
3 / 9 |
0 / 2 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Agranulocytosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Thrombotic microangiopathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aplasia pure red cell
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Febrile neutropenia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Granulocytopenia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemolysis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercoagulation
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sickle cell anaemia with crisis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
|
Vertigo
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
|
Cataract
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Eyelid ptosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular fibrosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Macular oedema
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal detachment
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Uveitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
|
Diarrhoea
|
|
|
|
subjects affected / exposed
|
18 / 183 (9.84%) |
14 / 177 (7.91%) |
10 / 179 (5.59%) |
occurrences causally related to treatment / all
|
1 / 20 |
5 / 16 |
1 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vomiting
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
3 / 177 (1.69%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gastritis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gastric ulcer
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Ileus
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Small intestine obstruction
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Colitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hernial eventration
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
Large intestine polyp
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aphthous stomatitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Constipation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenal perforation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastrointestinal ulcer
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gingival hyperplasia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gingival hypertrophy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal fistula
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Malabsorption
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral disorder
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Stomatitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Volvulus
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
|
Cholelithiasis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Biliary dilatation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cyst
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic steatosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
|
Skin ulcer
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Angioedema
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Blister
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic bullosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rash
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
|
Renal failure acute
|
|
|
|
subjects affected / exposed
|
7 / 183 (3.83%) |
12 / 177 (6.78%) |
11 / 179 (6.15%) |
occurrences causally related to treatment / all
|
1 / 17 |
1 / 12 |
2 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
5 / 177 (2.82%) |
7 / 179 (3.91%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
3 / 177 (1.69%) |
9 / 179 (5.03%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
2 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
3 / 177 (1.69%) |
4 / 179 (2.23%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Haematuria
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
3 / 177 (1.69%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 3 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal vein thrombosis
|
|
|
|
subjects affected / exposed
|
6 / 183 (3.28%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary fistula
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary incontinence
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery thrombosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal haemorrhage
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular disorder
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vesicoureteric reflux
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder prolapse
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder neck sclerosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bladder obstruction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysuria
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypertonic bladder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Microalbuminuria
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephritis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perinephric effusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postrenal failure
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Prerenal failure
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelocaliectasis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal artery dissection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal failure chronic
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal tubular atrophy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteral necrosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric dilatation
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric fistula
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urethral obstruction
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urine abnormality
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Vesical fistula
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
|
Adrenal mass
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Hyperparathyroidism
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperparathyroidism tertiary
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
|
Arthritis
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Back pain
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bursitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diastasis recti abdominis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fistula
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercreatinaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc disorder
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mobility decreased
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Myopathy
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Neck pain
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Post transplant distal limb syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Synovitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tenosynovitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
|
Urinary tract infection
|
|
|
|
subjects affected / exposed
|
25 / 183 (13.66%) |
28 / 177 (15.82%) |
26 / 179 (14.53%) |
occurrences causally related to treatment / all
|
8 / 39 |
6 / 36 |
9 / 47 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
|
subjects affected / exposed
|
18 / 183 (9.84%) |
16 / 177 (9.04%) |
13 / 179 (7.26%) |
occurrences causally related to treatment / all
|
17 / 29 |
10 / 18 |
4 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
|
subjects affected / exposed
|
15 / 183 (8.20%) |
14 / 177 (7.91%) |
11 / 179 (6.15%) |
occurrences causally related to treatment / all
|
6 / 21 |
8 / 20 |
4 / 13 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 2 |
Sepsis
|
|
|
|
subjects affected / exposed
|
8 / 183 (4.37%) |
10 / 177 (5.65%) |
15 / 179 (8.38%) |
occurrences causally related to treatment / all
|
1 / 10 |
2 / 10 |
4 / 16 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 3 |
2 / 4 |
Pyelonephritis
|
|
|
|
subjects affected / exposed
|
12 / 183 (6.56%) |
6 / 177 (3.39%) |
14 / 179 (7.82%) |
occurrences causally related to treatment / all
|
4 / 17 |
3 / 6 |
2 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
Gatroenteritis
|
|
|
|
subjects affected / exposed
|
8 / 183 (4.37%) |
6 / 177 (3.39%) |
8 / 179 (4.47%) |
occurrences causally related to treatment / all
|
1 / 8 |
2 / 6 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
|
subjects affected / exposed
|
6 / 183 (3.28%) |
7 / 177 (3.95%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
2 / 8 |
1 / 7 |
3 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
Herpes zoster
|
|
|
|
subjects affected / exposed
|
8 / 183 (4.37%) |
3 / 177 (1.69%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
3 / 8 |
1 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
1 / 177 (0.56%) |
7 / 179 (3.91%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Septic shock
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
1 / 5 |
Bacteraemia
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
5 / 179 (2.79%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
3 / 177 (1.69%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 3 |
0 / 3 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
|
subjects affected / exposed
|
5 / 183 (2.73%) |
4 / 177 (2.26%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
2 / 5 |
1 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
5 / 179 (2.79%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
2 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
3 / 177 (1.69%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
3 / 4 |
2 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gangrene
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
|
subjects affected / exposed
|
4 / 183 (2.19%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Pneumocystis jirovecii pneumonia
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
2 / 3 |
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 2 |
2 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection pseudomonal
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
2 / 4 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
2 / 3 |
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bronchopneumonia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
4 / 177 (2.26%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
Device related infection
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatic cyst infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Polyomavirus-associated nephropathy
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 3 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
Wound infection
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
2 / 2 |
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cryptococcosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
3 / 177 (1.69%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Cytomegalovirus viraemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
3 / 179 (1.68%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
3 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Meningitis cryptococcal
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
2 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
1 / 1 |
0 / 0 |
Pseudomonal sepsis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
3 / 3 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial pyelonephritis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus colitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Renal cyst infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Transplant abscess
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abdominal abscess
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Aspergillus infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Endocarditis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected lymphocele
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Localised infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
Pneumonia klebsiella
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Strongyloidiasis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
3 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Viral infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Abscess rupture
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Asymptomatic bacteriuria
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
BK virus infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Bacterial prostatitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral aspergillosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cerebral fungal infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Chorioretinitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus chorioretinitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus enteritis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus gastritis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus gastroenteritis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus gastrointestinal infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus hepatitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cytomegalovirus syndrome
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Disseminated cytomegaloviral infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Dysentery
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Emphysematous cystitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Encephalomyelitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fungal infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Helicobacter infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Herpes zoster disseminated
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Human polyomavirus infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Incision site infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infected cyst
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Influenza
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Joint tuberculosis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Klebsiella infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Leishmaniasis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lobar pneumonia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Lung infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Lymphangitis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Mycoplasma infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Oral fungal infection
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia cryptococcal
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia cytomegaloviral
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Pneumonia fungal
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Progressive multifocal leukoencephalopathy
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
Pseudomonas infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Psoas abscess
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Purulent discharge
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Respiratory tract infection fungal
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Sinusitis bacterial
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis of eye
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Tuberculosis laryngitis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Varicella
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
|
Dehydration
|
|
|
|
subjects affected / exposed
|
7 / 183 (3.83%) |
10 / 177 (5.65%) |
6 / 179 (3.35%) |
occurrences causally related to treatment / all
|
1 / 7 |
2 / 11 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
|
subjects affected / exposed
|
3 / 183 (1.64%) |
4 / 177 (2.26%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
3 / 177 (1.69%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
1 / 2 |
1 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
1 / 177 (0.56%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
2 / 177 (1.13%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Gout
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
|
subjects affected / exposed
|
2 / 183 (1.09%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
2 / 179 (1.12%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Cachexia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
|
subjects affected / exposed
|
1 / 183 (0.55%) |
0 / 177 (0.00%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypercreatininaemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
0 / 177 (0.00%) |
1 / 179 (0.56%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |
Obesity
|
|
|
|
subjects affected / exposed
|
0 / 183 (0.00%) |
1 / 177 (0.56%) |
0 / 179 (0.00%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
0 / 0 |