Serious adverse events
|
Vadadustat |
Darbepoetin Alfa |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
973 / 1768 (55.03%) |
1032 / 1769 (58.34%) |
number of deaths (all causes)
|
276 |
290 |
number of deaths resulting from adverse events
|
266 |
276 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Clear cell renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
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 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal neoplasm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma pancreas
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Benign ovarian tumour
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Borderline ovarian tumour
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Carcinoid tumour
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic lymphocytic leukaemia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Follicular thyroid cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genitourinary tract neoplasm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glioma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung carcinoma cell type unspecified stage IV
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung squamous cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant neoplasm of pleura
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningioma benign
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mixed hepatocellular cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal adenocarcinoma stage II
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraneoplastic syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pelvic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural mesothelioma malignant
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer stage II
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Refractory cytopenia with unilineage dysplasia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal adenoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma stage I
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoma metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid neoplasm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval cancer stage 0
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Hypotension
|
|
|
subjects affected / exposed
|
29 / 1768 (1.64%) |
30 / 1769 (1.70%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive urgency
|
|
|
subjects affected / exposed
|
19 / 1768 (1.07%) |
25 / 1769 (1.41%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertension
|
|
|
subjects affected / exposed
|
20 / 1768 (1.13%) |
22 / 1769 (1.24%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
16 / 1768 (0.90%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 21 |
1 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
12 / 1768 (0.68%) |
13 / 1769 (0.73%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
13 / 1768 (0.74%) |
10 / 1769 (0.57%) |
occurrences causally related to treatment / all
|
1 / 13 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
13 / 1768 (0.74%) |
10 / 1769 (0.57%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein thrombosis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shock
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Dry gangrene
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Steal syndrome
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant hypertension
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein occlusion
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava syndrome
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous stenosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis superficial
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Superior vena cava occlusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accelerated hypertension
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial insufficiency
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Axillary vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Distributive shock
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolism venous
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Iliac artery stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis ischaemic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic shock
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive shock
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post thrombotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein occlusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subgaleal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Superior vena cava stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis necrotising
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vein rupture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Hospitalisation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Therapy cessation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Arteriovenous fistula operation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac pacemaker insertion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemodialysis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal polypectomy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procoagulant therapy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access placement
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breech presentation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cephalhaematoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Premature baby
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical incompetence
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
General disorders and administration site conditions
|
|
|
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
34 / 1768 (1.92%) |
22 / 1769 (1.24%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 22 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Death
|
|
|
subjects affected / exposed
|
24 / 1768 (1.36%) |
14 / 1769 (0.79%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 24 |
0 / 14 |
Chest pain
|
|
|
subjects affected / exposed
|
14 / 1768 (0.79%) |
15 / 1769 (0.85%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden death
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 9 |
Pyrexia
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
Catheter site thrombosis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
1 / 5 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired healing
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised oedema
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Physical deconditioning
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Treatment noncompliance
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Catheter site pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complication associated with device
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral swelling
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical failure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac death
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Catheter site inflammation
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site related reaction
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug withdrawal syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothermia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue inflammation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulcer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent occlusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Kidney transplant rejection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic reaction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contrast media allergy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contrast media reaction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food allergy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal transplant failure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Social circumstances
|
|
|
Living in residential institution
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reproductive system and breast disorders
|
|
|
Dysfunctional uterine bleeding
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balanoposthitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menometrorrhagia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Penile vascular disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metrorrhagia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst ruptured
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fluid collection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular oedema
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 respiratory failure
|
|
|
subjects affected / exposed
|
44 / 1768 (2.49%) |
50 / 1769 (2.83%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 55 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 6 |
Respiratory failure
|
|
|
subjects affected / exposed
|
27 / 1768 (1.53%) |
42 / 1769 (2.37%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 42 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 9 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
26 / 1768 (1.47%) |
33 / 1769 (1.87%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleural effusion
|
|
|
subjects affected / exposed
|
26 / 1768 (1.47%) |
26 / 1769 (1.47%) |
occurrences causally related to treatment / all
|
0 / 30 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
19 / 1768 (1.07%) |
13 / 1769 (0.73%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
16 / 1768 (0.90%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea
|
|
|
subjects affected / exposed
|
19 / 1768 (1.07%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
10 / 1769 (0.57%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
1 / 6 |
2 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Asthma
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epistaxis
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Respiratory distress
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic respiratory failure
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atelectasis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory acidosis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercapnia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cough
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diaphragmatic disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiccups
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoventilation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal oedema
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung opacity
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal oedema
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Productive cough
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary alveolar haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Mental status changes
|
|
|
subjects affected / exposed
|
11 / 1768 (0.62%) |
23 / 1769 (1.30%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delirium
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Confusional state
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute stress disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol abuse
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alcohol withdrawal syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Delirium tremens
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression suicidal
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination, visual
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Major depression
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic stress disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Substance abuse
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device dislocation
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device malfunction
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device extrusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device leakage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device physical property issue
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patient-device incompatibility
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholelithiasis
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholecystitis
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute hepatic failure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bile duct stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis obstructive
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatic failure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatic haematoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic mass
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Hepatic enzyme increased
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Alanine aminotransferase increased
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspartate aminotransferase increased
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transaminases increased
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test increased
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anticoagulation drug level above therapeutic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
False positive investigation result
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ammonia increased
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood alkaline phosphatase increased
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ejection fraction decreased
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrocardiogram QT prolonged
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoglobin decreased
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart rate increased
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza B virus test positive
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver function test abnormal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus test positive
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury, poisoning and procedural complications
|
|
|
Arteriovenous fistula thrombosis
|
|
|
subjects affected / exposed
|
56 / 1768 (3.17%) |
38 / 1769 (2.15%) |
occurrences causally related to treatment / all
|
2 / 66 |
7 / 46 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft thrombosis
|
|
|
subjects affected / exposed
|
22 / 1768 (1.24%) |
20 / 1769 (1.13%) |
occurrences causally related to treatment / all
|
1 / 28 |
1 / 31 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
17 / 1768 (0.96%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site complication
|
|
|
subjects affected / exposed
|
16 / 1768 (0.90%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site haemorrhage
|
|
|
subjects affected / exposed
|
11 / 1768 (0.62%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
15 / 1768 (0.85%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access malfunction
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
10 / 1769 (0.57%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site thrombosis
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
13 / 1769 (0.73%) |
occurrences causally related to treatment / all
|
0 / 8 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hip fracture
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
11 / 1769 (0.62%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Ankle fracture
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm ruptured
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula aneurysm
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft thrombosis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Humerus fracture
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxicity to various agents
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pubis fracture
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula occlusion
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rib fracture
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Delayed graft function
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eschar
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Road traffic accident
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal dialysis complication
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative hypotension
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt thrombosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site pseudoaneurysm
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site haematoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Overdose
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative respiratory failure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal lymphocele
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin laceration
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site complication
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Accidental overdose
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic leak
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anastomotic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial injury
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site haematoma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compression fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dialysis disequilibrium syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrostomy tube site complication
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site impaired healing
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site swelling
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammation of wound
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injury
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation postoperative
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney rupture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meniscus injury
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal injury
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Poisoning deliberate
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post concussion syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural bile leak
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural diarrhoea
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural discharge
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural fever
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural swelling
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural shock
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reactive gastropathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Scapula fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seroma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin injury
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue injury
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic rupture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic fracture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Unintentional medical device removal
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access complication
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site rupture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound complication
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital, familial and genetic disorders
|
|
|
Gastrointestinal arteriovenous malformation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic arteriovenous malformation
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
81 / 1768 (4.58%) |
78 / 1769 (4.41%) |
occurrences causally related to treatment / all
|
1 / 97 |
3 / 89 |
deaths causally related to treatment / all
|
0 / 14 |
1 / 6 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
49 / 1768 (2.77%) |
60 / 1769 (3.39%) |
occurrences causally related to treatment / all
|
0 / 52 |
0 / 61 |
deaths causally related to treatment / all
|
0 / 35 |
0 / 37 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
45 / 1768 (2.55%) |
50 / 1769 (2.83%) |
occurrences causally related to treatment / all
|
1 / 54 |
0 / 57 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
44 / 1768 (2.49%) |
37 / 1769 (2.09%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 43 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
28 / 1768 (1.58%) |
32 / 1769 (1.81%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
28 / 1768 (1.58%) |
26 / 1769 (1.47%) |
occurrences causally related to treatment / all
|
0 / 31 |
1 / 26 |
deaths causally related to treatment / all
|
0 / 22 |
0 / 23 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
18 / 1768 (1.02%) |
26 / 1769 (1.47%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 29 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
13 / 1768 (0.74%) |
23 / 1769 (1.30%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
14 / 1769 (0.79%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 9 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 3 |
Angina unstable
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
13 / 1769 (0.73%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
11 / 1769 (0.62%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Angina pectoris
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
11 / 1769 (0.62%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Atrial flutter
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradycardia
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
11 / 1769 (0.62%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 5 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 2 |
1 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic left ventricular failure
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 2 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pericarditis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block first degree
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diastolic dysfunction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nodal arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Ventricular arrhythmia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiomegaly
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiovascular disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cor pulmonale
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dressler's syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac mass
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracardiac thrombus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Left ventricular hypertrophy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve calcification
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve disease
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis uraemic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Silent myocardial infarction
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular hypokinesia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
20 / 1768 (1.13%) |
25 / 1769 (1.41%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Syncope
|
|
|
subjects affected / exposed
|
22 / 1768 (1.24%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
14 / 1768 (0.79%) |
16 / 1769 (0.90%) |
occurrences causally related to treatment / all
|
1 / 15 |
3 / 16 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Encephalopathy
|
|
|
subjects affected / exposed
|
13 / 1768 (0.74%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Ischaemic stroke
|
|
|
subjects affected / exposed
|
13 / 1768 (0.74%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 5 |
Seizure
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
14 / 1769 (0.79%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
15 / 1768 (0.85%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
1 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Dizziness
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Presyncope
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain injury
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uraemic encephalopathy
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Brain oedema
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar infarction
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Embolic stroke
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic encephalopathy
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurotoxicity
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Toxic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amnesia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Amputation stump pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basal ganglia infarction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carotid artery aneurysm
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lupus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery occlusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral microhaemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic hyperosmolar coma
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyskinesia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Focal dyscognitive seizures
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperammonaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jugular vein occlusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar radiculopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microvascular cranial nerve palsy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathy peripheral
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraesthesia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Partial seizures
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post cardiac arrest syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postictal state
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiculopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal cord compression
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasogenic cerebral oedema
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral artery stenosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
35 / 1768 (1.98%) |
37 / 1769 (2.09%) |
occurrences causally related to treatment / all
|
2 / 38 |
0 / 40 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood loss anaemia
|
|
|
subjects affected / exposed
|
16 / 1768 (0.90%) |
24 / 1769 (1.36%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 34 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukocytosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Autoimmune haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bicytopenia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic diathesis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leukopenia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Macrocytosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normocytic anaemia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic artery perforation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenomegaly
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear and labyrinth disorders
|
|
|
Vertigo
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo positional
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blindness unilateral
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diplopia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mydriasis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uveitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal disorders
|
|
|
Gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
34 / 1768 (1.92%) |
29 / 1769 (1.64%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Abdominal pain
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
2 / 9 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Diarrhoea
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Impaired gastric emptying
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Pancreatitis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Melaena
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
1 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hiatus hernia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal distension
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia obstructive
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysphagia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer perforation
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus paralytic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal haematoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obstructive pancreatitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal adhesions
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall oedema
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastropathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dieulafoy's vascular malformation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal polyp
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epigastric discomfort
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiectasia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal inflammation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal vascular malformation haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal wall thickening
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoaesthesia oral
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal ulcer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inflammatory bowel disease
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia, obstructive
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intussusception
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Irritable bowel syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal obstruction
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal motility disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic duct dilatation
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumoperitoneum
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Portal hypertensive gastropathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal ulcer
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis mesenteric vessel
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uraemic gastropathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Diabetic foot
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin ulcer
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Angioedema
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin necrosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blister
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cutaneous vasculitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis contact
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hidradenitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stevens-Johnson syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
End stage renal disease
|
|
|
subjects affected / exposed
|
15 / 1768 (0.85%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 11 |
0 / 6 |
Azotaemia
|
|
|
subjects affected / exposed
|
10 / 1768 (0.57%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Acute kidney injury
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Haematuria
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Tubulointerstitial nephritis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neurogenic bladder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst ruptured
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal impairment
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal infarct
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal mass
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal tubular necrosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric obstruction
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder rupture
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism secondary
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperthyroidism
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism tertiary
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal mass
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid mass
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Back pain
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
9 / 1769 (0.51%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoarthritis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
1 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myopathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone metabolism disorder
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondrocalcinosis pyrophosphate
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease-mineral and bone disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Costochondritis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture nonunion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma muscle
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hungry bone syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc degeneration
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteochondrosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in jaw
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylolysis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigger finger
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Pneumonia
|
|
|
subjects affected / exposed
|
140 / 1768 (7.92%) |
119 / 1769 (6.73%) |
occurrences causally related to treatment / all
|
0 / 180 |
0 / 142 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 6 |
Sepsis
|
|
|
subjects affected / exposed
|
76 / 1768 (4.30%) |
88 / 1769 (4.97%) |
occurrences causally related to treatment / all
|
0 / 83 |
0 / 96 |
deaths causally related to treatment / all
|
0 / 13 |
0 / 13 |
Septic shock
|
|
|
subjects affected / exposed
|
44 / 1768 (2.49%) |
45 / 1769 (2.54%) |
occurrences causally related to treatment / all
|
0 / 46 |
0 / 47 |
deaths causally related to treatment / all
|
0 / 23 |
0 / 21 |
Cellulitis
|
|
|
subjects affected / exposed
|
43 / 1768 (2.43%) |
38 / 1769 (2.15%) |
occurrences causally related to treatment / all
|
0 / 47 |
0 / 41 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
31 / 1768 (1.75%) |
39 / 1769 (2.20%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 47 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peritonitis
|
|
|
subjects affected / exposed
|
21 / 1768 (1.19%) |
32 / 1769 (1.81%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Device related infection
|
|
|
subjects affected / exposed
|
25 / 1768 (1.41%) |
23 / 1769 (1.30%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gangrene
|
|
|
subjects affected / exposed
|
24 / 1768 (1.36%) |
23 / 1769 (1.30%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
15 / 1768 (0.85%) |
32 / 1769 (1.81%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
20 / 1768 (1.13%) |
15 / 1769 (0.85%) |
occurrences causally related to treatment / all
|
0 / 21 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
16 / 1768 (0.90%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
17 / 1768 (0.96%) |
15 / 1769 (0.85%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
12 / 1768 (0.68%) |
19 / 1769 (1.07%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site infection
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
14 / 1769 (0.79%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
8 / 1768 (0.45%) |
14 / 1769 (0.79%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bacteraemia
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
11 / 1769 (0.62%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
15 / 1769 (0.85%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Arteriovenous fistula site infection
|
|
|
subjects affected / exposed
|
12 / 1768 (0.68%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
12 / 1769 (0.68%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
9 / 1768 (0.51%) |
10 / 1769 (0.57%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
13 / 1769 (0.73%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Device related sepsis
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
7 / 1769 (0.40%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess limb
|
|
|
subjects affected / exposed
|
7 / 1768 (0.40%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
8 / 1769 (0.45%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site infection
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
4 / 1768 (0.23%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cytomegalovirus infection
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urosepsis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal peritonitis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gas gangrene
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine infection
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia viral
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal bacteraemia
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular access site infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral infection
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatitis B
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis infective
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Endocarditis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia bacteraemia
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia influenzal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenovirus infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis infective
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical pneumonia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Breast abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic hepatitis B
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
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
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Orchitis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perineal abscess
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia necrotising
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia serratia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural cellulitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
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
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal graft infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Scrotal abscess
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal osteomyelitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular device infection
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vulval abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess jaw
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess neck
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Achromobacter infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical mycobacterial pneumonia
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial diarrhoea
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacteriuria
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bullous impetigo
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Candida sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbuncle
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral septic infarct
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colonic abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Conjunctivitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corona virus infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis klebsiella
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ear infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Emphysematous cholecystitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fournier's gangrene
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal bacterial overgrowth
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal viral infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genital herpes
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Giardiasis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site cellulitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incision site abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected seroma
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (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
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Labyrinthitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mastoiditis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Meningitis viral
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mycobacterium fortuitum infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal candidiasis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral candidiasis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis bacterial
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraspinal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perinephric abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital cellulitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirectal abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngeal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis streptococcal
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia cytomegaloviral
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia haemophilus
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia moraxella
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia mycoplasmal
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pseudomonal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonas peritonitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
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
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyuria
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus bronchitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal abscess
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhinovirus infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhodococcus infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic embolus
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheitis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tracheobronchitis viral
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant abscess
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection bacterial
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vessel puncture site infection
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral diarrhoea
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral sepsis
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Fluid overload
|
|
|
subjects affected / exposed
|
98 / 1768 (5.54%) |
98 / 1769 (5.54%) |
occurrences causally related to treatment / all
|
0 / 138 |
0 / 132 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
55 / 1768 (3.11%) |
76 / 1769 (4.30%) |
occurrences causally related to treatment / all
|
1 / 60 |
1 / 89 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
22 / 1768 (1.24%) |
18 / 1769 (1.02%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
6 / 1769 (0.34%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
5 / 1768 (0.28%) |
5 / 1769 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
6 / 1768 (0.34%) |
3 / 1769 (0.17%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
3 / 1768 (0.17%) |
4 / 1769 (0.23%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calciphylaxis
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Dehydration
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
2 / 1769 (0.11%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Failure to thrive
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
2 / 1768 (0.11%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemosiderosis
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperglycaemic hyperosmolar nonketotic syndrome
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperphosphataemia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypomagnesaemia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
0 / 1768 (0.00%) |
1 / 1769 (0.06%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1768 (0.06%) |
0 / 1769 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |