Serious adverse events
|
Placebo |
Roxadustat |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
749 / 1377 (54.39%) |
795 / 1384 (57.44%) |
number of deaths (all causes)
|
245 |
284 |
number of deaths resulting from adverse events
|
213 |
262 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer female
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast neoplasm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon cancer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottic carcinoma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric adenoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric neoplasm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leiomyoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm of appendix
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine tumour of the lung
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ovarian cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Prostate cancer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the vagina
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Accelerated hypertension
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Aortic rupture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriovenous fistula
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
15 / 1384 (1.08%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Distributive shock
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dry gangrene
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
16 / 1377 (1.16%) |
17 / 1384 (1.23%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
27 / 1377 (1.96%) |
33 / 1384 (2.38%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 51 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
21 / 1377 (1.53%) |
21 / 1384 (1.52%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
6 / 1377 (0.44%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Iliac artery perforation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphocele
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paget-Schroetter syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pallor
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral venous disease
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Steal syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose ulceration
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular occlusion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visceral congestion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pregnancy, puerperium and perinatal conditions
|
|
|
Abortion spontaneous
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Asthenia
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
13 / 1384 (0.94%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
28 / 1377 (2.03%) |
43 / 1384 (3.11%) |
occurrences causally related to treatment / all
|
1 / 28 |
0 / 43 |
deaths causally related to treatment / all
|
1 / 28 |
0 / 43 |
Device related thrombosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
17 / 1384 (1.23%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia pain
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site extravasation
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site necrosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema due to renal disease
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pacemaker generated arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyrexia
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
11 / 1377 (0.80%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 5 |
Immune system disorders
|
|
|
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device allergy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney transplant rejection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal transplant failure
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysfunctional uterine bleeding
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst ruptured
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst torsion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian mass
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic prolapse
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic fibrosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatic mass
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatomegaly
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory, thoracic and mediastinal disorders
|
|
|
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
22 / 1377 (1.60%) |
13 / 1384 (0.94%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
20 / 1377 (1.45%) |
12 / 1384 (0.87%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial fistula
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
12 / 1377 (0.87%) |
11 / 1384 (0.79%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Laryngeal stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive airways disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
16 / 1377 (1.16%) |
15 / 1384 (1.08%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural thickening
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pneumonitis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary fibrosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
16 / 1377 (1.16%) |
17 / 1384 (1.23%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Respiratory alkalosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory distress
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory failure
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 2 |
Tracheal stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract inflammation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Insomnia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
2 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paranoia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular cognitive impairment
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Bile duct stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haemorrhagic hepatic cyst
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis alcoholic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperbilirubinaemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Anticoagulation drug level increased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bicarbonate decreased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood bilirubin increased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatine increased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood creatinine increased
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose abnormal
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood glucose increased
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure decreased
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood pressure increased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Blood urine present
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation factor decreased
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Anastomotic stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula occlusion
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site complication
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula thrombosis
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
18 / 1384 (1.30%) |
occurrences causally related to treatment / all
|
1 / 9 |
1 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical peritonitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chemical poisoning
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Comminuted fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dialysis disequilibrium syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dialysis related complication
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fractured sacrum
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heat stroke
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
6 / 1377 (0.44%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Joint dislocation
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip injury
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal dialysis complication
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt malfunction
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt occlusion
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord injury cervical
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spleen contusion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma obstruction
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma site haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thermal burn
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant dysfunction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic liver injury
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access malfunction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site thrombosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haematoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Congenital cystic kidney disease
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
27 / 1377 (1.96%) |
26 / 1384 (1.88%) |
occurrences causally related to treatment / all
|
1 / 31 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 6 |
Angina pectoris
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
10 / 1384 (0.72%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angina unstable
|
|
|
subjects affected / exposed
|
10 / 1377 (0.73%) |
10 / 1384 (0.72%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
12 / 1377 (0.87%) |
10 / 1384 (0.72%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial flutter
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
9 / 1384 (0.65%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 6 |
Cardiac asthma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
32 / 1377 (2.32%) |
25 / 1384 (1.81%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
14 / 1377 (1.02%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 3 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
31 / 1377 (2.25%) |
33 / 1384 (2.38%) |
occurrences causally related to treatment / all
|
1 / 42 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 7 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 5 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
12 / 1384 (0.87%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular dysfunction
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
13 / 1377 (0.94%) |
14 / 1384 (1.01%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 6 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus arrest
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nervous system disorders
|
|
|
Aphasia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autonomic nervous system imbalance
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
9 / 1384 (0.65%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
13 / 1384 (0.94%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
11 / 1377 (0.80%) |
15 / 1384 (1.08%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical cord compression
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Coma uraemic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Demyelination
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperosmolar coma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidotic hyperglycaemic coma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dizziness
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial spasm
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
6 / 1377 (0.44%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Headache
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intercostal neuralgia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
9 / 1384 (0.65%) |
occurrences causally related to treatment / all
|
0 / 7 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurodegenerative disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neuroleptic malignant syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Occipital neuralgia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post stroke seizure
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seizure
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Senile dementia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamic infarction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uraemic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebrobasilar insufficiency
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo CNS origin
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular migraine
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Evans syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile neutropenia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic uraemic syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Histiocytosis haematophagic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocoagulable state
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency anaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Vertigo
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular ataxia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular disorder
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Blindness unilateral
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcerative keratitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual acuity reduced
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Abdominal adhesions
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain lower
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal incontinence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Crohn's disease
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastropathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
9 / 1384 (0.65%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral hernia incarcerated
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Functional gastrointestinal disorder
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric polyps
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
15 / 1377 (1.09%) |
18 / 1384 (1.30%) |
occurrences causally related to treatment / all
|
1 / 18 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
15 / 1377 (1.09%) |
20 / 1384 (1.45%) |
occurrences causally related to treatment / all
|
0 / 16 |
1 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
1 / 3 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic ascites
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal perforation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric artery thrombosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal varices haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic cyst
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal adhesions
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal cloudy effluent
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumatosis intestinalis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
11 / 1384 (0.79%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Uraemic gastropathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Blister
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis atopic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrobiosis lipoidica diabeticorum
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papule
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rash
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stevens-Johnson syndrome
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic epidermal necrolysis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
Acute kidney injury
|
|
|
subjects affected / exposed
|
32 / 1377 (2.32%) |
41 / 1384 (2.96%) |
occurrences causally related to treatment / all
|
0 / 33 |
0 / 48 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Anuria
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Azotaemia
|
|
|
subjects affected / exposed
|
60 / 1377 (4.36%) |
61 / 1384 (4.41%) |
occurrences causally related to treatment / all
|
0 / 79 |
0 / 73 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 14 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 7 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic nephropathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
End stage renal disease
|
|
|
subjects affected / exposed
|
201 / 1377 (14.60%) |
199 / 1384 (14.38%) |
occurrences causally related to treatment / all
|
0 / 211 |
1 / 211 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 11 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Haematuria
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephritic syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive uropathy
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedematous kidney
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oliguria
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyuria
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelocaliectasis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal atrophy
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal papillary necrosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal pelvis fistula
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary fistula
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract inflammation
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism secondary
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Arthralgia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site infection
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve abscess
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site cellulitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis
|
|
|
subjects affected / exposed
|
13 / 1377 (0.94%) |
24 / 1384 (1.73%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridial infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cytomegalovirus nephritis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dengue fever
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
14 / 1384 (1.01%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cystitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endotoxic shock
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal oesophagitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal peritonitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Furuncle
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
7 / 1377 (0.51%) |
10 / 1384 (0.72%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
8 / 1377 (0.58%) |
13 / 1384 (0.94%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Helicobacter gastritis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis B reactivation
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis C
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes virus infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected lymphocele
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective aneurysm
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Localised infection
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymph node tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media chronic
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parvovirus infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric abscess
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis
|
|
|
subjects affected / exposed
|
14 / 1377 (1.02%) |
15 / 1384 (1.08%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia
|
|
|
subjects affected / exposed
|
88 / 1377 (6.39%) |
113 / 1384 (8.16%) |
occurrences causally related to treatment / all
|
1 / 107 |
0 / 149 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 12 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural pneumonia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonas infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Purulence
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
5 / 1377 (0.36%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
11 / 1377 (0.80%) |
11 / 1384 (0.79%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pyoderma
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyonephrosis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sepsis
|
|
|
subjects affected / exposed
|
23 / 1377 (1.67%) |
49 / 1384 (3.54%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 51 |
deaths causally related to treatment / all
|
0 / 8 |
0 / 26 |
Septic shock
|
|
|
subjects affected / exposed
|
15 / 1377 (1.09%) |
18 / 1384 (1.30%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 14 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stenotrophomonas sepsis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal endocarditis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Taeniasis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
5 / 1384 (0.36%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Typhoid fever
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
26 / 1377 (1.89%) |
36 / 1384 (2.60%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
6 / 1377 (0.44%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Vascular access site infection
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vestibular neuronitis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Acidosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adult failure to thrive
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calciphylaxis
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
8 / 1384 (0.58%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
10 / 1377 (0.73%) |
6 / 1384 (0.43%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Failure to thrive
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid overload
|
|
|
subjects affected / exposed
|
22 / 1377 (1.60%) |
20 / 1384 (1.45%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food aversion
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
9 / 1377 (0.65%) |
16 / 1384 (1.16%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperinsulinaemic hypoglycaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
25 / 1377 (1.82%) |
41 / 1384 (2.96%) |
occurrences causally related to treatment / all
|
0 / 35 |
2 / 53 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hypernatraemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperuricaemia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
0 / 1377 (0.00%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
2 / 1384 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
26 / 1377 (1.89%) |
32 / 1384 (2.31%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
6 / 1377 (0.44%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
3 / 1384 (0.22%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iron deficiency
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketoacidosis
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ketosis
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
0 / 1384 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
4 / 1377 (0.29%) |
4 / 1384 (0.29%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
3 / 1377 (0.22%) |
7 / 1384 (0.51%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 1377 (0.15%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1377 (0.07%) |
1 / 1384 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |