Serious adverse events
|
Methoxy Polyethylene Glycol-Epoetin Beta |
Erythropoiesis Stimulating Agents |
Total subjects affected by serious adverse events
|
|
|
subjects affected / exposed
|
1097 / 1409 (77.86%) |
1123 / 1409 (79.70%) |
number of deaths (all causes)
|
558 |
557 |
number of deaths resulting from adverse events
|
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
|
|
Basal cell carcinoma
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to liver
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Renal cell carcinoma
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
1 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder neoplasm
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colon cancer metastatic
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Myelodysplastic syndrome
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
2 / 6 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cancer
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Squamous cell carcinoma of skin
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adenocarcinoma of colon
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon adenoma
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Rectal cancer
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cholangiocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Intestinal adenocarcinoma
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal cancer metastatic
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Skin cancer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
B-cell lymphoma
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colon cancer
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon neoplasm
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal tract adenoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung neoplasm malignant
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant pleural effusion
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastases to central nervous system
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Metastases to lung
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pancreatic carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pituitary tumour benign
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of lung
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Transitional cell carcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bladder papilloma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone neoplasm
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Colorectal cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Gastric cancer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatocellular carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to bone
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic carcinoma of the bladder
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Metastatic malignant melanoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Neuroendocrine tumour
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Papillary thyroid cancer
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostate cancer recurrent
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Rectal adenocarcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
2 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal neoplasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Squamous cell carcinoma of the tongue
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid adenoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute myeloid leukaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Acute myelomonocytic leukaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adenoma benign
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal adenoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign lung neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of bladder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign neoplasm of epididymis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Benign urinary tract neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder transitional cell carcinoma metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Brain neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cancer pain
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the duodenum
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoid tumour of the stomach
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carcinoma in situ of penis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system lymphoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Central nervous system neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral hygroma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervix carcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Choroid melanoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic myeloid leukaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colorectal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Connective tissue neoplasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ear neoplasm malignant
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial neoplasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Extranodal marginal zone B-cell lymphoma (malt type)
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stromal tumour
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic neoplasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Invasive ductal breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Invasive lobular breast carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Keratoacanthoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laryngeal papilloma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lentigo maligna
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malignant fibrous histiocytoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastases to peritoneum
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastases to spine
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Metastatic carcinoid tumour
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic gastric cancer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Metastatic renal cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metastatic squamous cell carcinoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelofibrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neoplasm skin
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuroendocrine carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-Hodgkin's lymphoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-small cell lung cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oesophageal adenocarcinoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Oligodendroglioma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian adenoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paget's disease of nipple
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatic carcinoma metastatic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Parathyroid tumour benign
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic neoplasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plasma cell myeloma recurrent
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal cancer metastatic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Rectal cancer recurrent
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectosigmoid cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Refractory cytopenia with unilineage dysplasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cell carcinoma recurrent
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haemangioma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small cell lung cancer metastatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Squamous cell carcinoma of the oral cavity
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Testicular neoplasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thymoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thyroid cancer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue neoplasm malignant stage unspecified
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tonsil cancer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transitional cell cancer of renal pelvis and ureter metastatic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Transitional cell carcinoma urethra
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Tumour haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder adenoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine leiomyoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular disorders
|
|
|
Peripheral ischaemia
|
|
|
subjects affected / exposed
|
31 / 1409 (2.20%) |
31 / 1409 (2.20%) |
occurrences causally related to treatment / all
|
1 / 39 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 5 |
Peripheral arterial occlusive disease
|
|
|
subjects affected / exposed
|
24 / 1409 (1.70%) |
24 / 1409 (1.70%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hypertension
|
|
|
subjects affected / exposed
|
23 / 1409 (1.63%) |
24 / 1409 (1.70%) |
occurrences causally related to treatment / all
|
1 / 33 |
2 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypotension
|
|
|
subjects affected / exposed
|
16 / 1409 (1.14%) |
18 / 1409 (1.28%) |
occurrences causally related to treatment / all
|
1 / 16 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Extremity necrosis
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hypertensive crisis
|
|
|
subjects affected / exposed
|
13 / 1409 (0.92%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Peripheral artery stenosis
|
|
|
subjects affected / exposed
|
12 / 1409 (0.85%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral vascular disorder
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic stenosis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Deep vein thrombosis
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
1 / 7 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Orthostatic hypotension
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Shock haemorrhagic
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Aortic aneurysm
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Steal syndrome
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dry gangrene
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intermittent claudication
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery occlusion
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Venous stenosis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Circulatory collapse
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Aortic aneurysm rupture
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 1 |
Brachiocephalic vein stenosis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery thrombosis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial disorder
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Granulomatosis with polyangiitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemic shock
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Vena cava thrombosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis limb
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial occlusive disease
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Shock
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Superior vena cava syndrome
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Angiodysplasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic dissection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial rupture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriosclerosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brachiocephalic vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic macroangiopathy
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic vascular disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive emergency
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Leriche syndrome
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral embolism
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phlebitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subclavian vein stenosis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombophlebitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular calcification
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous thrombosis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aneurysm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic thrombosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral artery dissection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic infarction
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic limb pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphatic fistula
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphoedema
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymphostasis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microangiopathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Microscopic polyangiitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic venous thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery aneurysm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicose vein
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitis necrotising
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Venous aneurysm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical and medical procedures
|
|
|
Oral surgery
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
|
|
Death
|
|
|
subjects affected / exposed
|
39 / 1409 (2.77%) |
33 / 1409 (2.34%) |
occurrences causally related to treatment / all
|
0 / 39 |
0 / 33 |
deaths causally related to treatment / all
|
0 / 39 |
0 / 33 |
Sudden death
|
|
|
subjects affected / exposed
|
44 / 1409 (3.12%) |
26 / 1409 (1.85%) |
occurrences causally related to treatment / all
|
0 / 44 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 44 |
0 / 26 |
Pyrexia
|
|
|
subjects affected / exposed
|
26 / 1409 (1.85%) |
30 / 1409 (2.13%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 39 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
General physical health deterioration
|
|
|
subjects affected / exposed
|
12 / 1409 (0.85%) |
16 / 1409 (1.14%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 11 |
Chest pain
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
1 / 10 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site haemorrhage
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Non-cardiac chest pain
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Asthenia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Inflammation
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple organ dysfunction syndrome
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 6 |
Complication associated with device
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden cardiac death
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Hyperthermia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adverse drug reaction
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related thrombosis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperpyrexia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malaise
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema due to renal disease
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fatigue
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hernia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema peripheral
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Swelling
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site inflammation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest discomfort
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gait disturbance
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Strangulated hernia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic inflammatory response syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Accidental death
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Discomfort
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug intolerance
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dysplasia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heteroplasia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Impaired healing
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site extravasation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated hernia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injection site extravasation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injection site scab
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Medical device pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mucosal ulceration
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oedema due to cardiac disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudocyst
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stent-graft endoleak
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Surgical failure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Treatment failure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent restenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular stent thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vessel puncture site haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune system disorders
|
|
|
Drug hypersensitivity
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypersensitivity
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney transplant rejection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaphylactic shock
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft versus host disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune reconstitution inflammatory syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreas transplant rejection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcoidosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transplant rejection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
|
|
Benign prostatic hyperplasia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Prostatitis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endometrial hyperplasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical dysplasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic ovarian cyst
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ovarian cyst
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postmenopausal haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Breast mass
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Female genital tract fistula
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Hysterocele
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Menorrhagia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Uterine polyp
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
|
|
Pleural effusion
|
|
|
subjects affected / exposed
|
22 / 1409 (1.56%) |
22 / 1409 (1.56%) |
occurrences causally related to treatment / all
|
0 / 23 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Non-cardiogenic pulmonary oedema
|
|
|
subjects affected / exposed
|
15 / 1409 (1.06%) |
23 / 1409 (1.63%) |
occurrences causally related to treatment / all
|
0 / 18 |
0 / 35 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Dyspnoea
|
|
|
subjects affected / exposed
|
16 / 1409 (1.14%) |
14 / 1409 (0.99%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 17 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Pulmonary oedema
|
|
|
subjects affected / exposed
|
18 / 1409 (1.28%) |
12 / 1409 (0.85%) |
occurrences causally related to treatment / all
|
1 / 19 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Acute pulmonary oedema
|
|
|
subjects affected / exposed
|
11 / 1409 (0.78%) |
14 / 1409 (0.99%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 4 |
Chronic obstructive pulmonary disease
|
|
|
subjects affected / exposed
|
12 / 1409 (0.85%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Respiratory failure
|
|
|
subjects affected / exposed
|
13 / 1409 (0.92%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 9 |
0 / 3 |
Pneumonia aspiration
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Epistaxis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary embolism
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
1 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Acute respiratory failure
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Pulmonary congestion
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lung disorder
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonitis
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Haemothorax
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aspiration
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Respiratory arrest
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Asthma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Respiratory distress
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Bronchitis chronic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchospasm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemoptysis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary hypertension
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sleep apnoea syndrome
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchial disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchiectasis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspnoea exertional
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrothorax
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Interstitial lung disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasal polyps
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pleurisy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumothorax
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pulmonary mass
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute lung injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute respiratory distress syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atelectasis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopneumopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
1 / 1409 (0.07%) |
0 / 1409 (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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Idiopathic pulmonary fibrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mediastinal effusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mendelson's syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nasal septum perforation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Painful respiration
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary arterial hypertension
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Reflux laryngitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory depression
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychiatric disorders
|
|
|
Confusional state
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
14 / 1409 (0.99%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Completed suicide
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Delirium
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hallucination
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depression
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sopor
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adjustment disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mania
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental status changes
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Organic brain syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Suicide attempt
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abnormal behaviour
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute psychosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anxiety disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bipolar disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug abuse
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mental disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Substance-induced psychotic disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Product issues
|
|
|
Device malfunction
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
1 / 9 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombosis in device
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device dislocation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device loosening
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device breakage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device damage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device extrusion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device failure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device occlusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatobiliary disorders
|
|
|
Cholecystitis
|
|
|
subjects affected / exposed
|
12 / 1409 (0.85%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis acute
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholelithiasis
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cholangitis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice cholestatic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bile duct stone
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic failure
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cholestasis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cirrhosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary colic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis acute
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Drug-induced liver injury
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute hepatic failure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Bile duct obstruction
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholecystitis chronic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cirrhosis alcoholic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder enlargement
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallbladder perforation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemobilia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hepatitis acute
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatotoxicity
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocholecystis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic hepatitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Jaundice
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigations
|
|
|
Weight decreased
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
International normalised ratio increased
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coagulation time prolonged
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Investigation abnormal
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Troponin increased
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
77 / 1409 (5.46%) |
110 / 1409 (7.81%) |
occurrences causally related to treatment / all
|
2 / 106 |
4 / 141 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site complication
|
|
|
subjects affected / exposed
|
47 / 1409 (3.34%) |
57 / 1409 (4.05%) |
occurrences causally related to treatment / all
|
0 / 65 |
0 / 69 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femur fracture
|
|
|
subjects affected / exposed
|
26 / 1409 (1.85%) |
23 / 1409 (1.63%) |
occurrences causally related to treatment / all
|
0 / 27 |
0 / 24 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriovenous fistula site haemorrhage
|
|
|
subjects affected / exposed
|
23 / 1409 (1.63%) |
16 / 1409 (1.14%) |
occurrences causally related to treatment / all
|
0 / 26 |
1 / 17 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft thrombosis
|
|
|
subjects affected / exposed
|
23 / 1409 (1.63%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
1 / 44 |
1 / 39 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Femoral neck fracture
|
|
|
subjects affected / exposed
|
14 / 1409 (0.99%) |
19 / 1409 (1.35%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Procedural hypotension
|
|
|
subjects affected / exposed
|
16 / 1409 (1.14%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula aneurysm
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
15 / 1409 (1.06%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haematoma
|
|
|
subjects affected / exposed
|
12 / 1409 (0.85%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 12 |
1 / 8 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 2 |
Hip fracture
|
|
|
subjects affected / exposed
|
11 / 1409 (0.78%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haemorrhage
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Rib fracture
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Head injury
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Humerus fracture
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fall
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple fractures
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Overdose
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic fracture
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar vertebral fracture
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Limb injury
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radius fracture
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ankle fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site stenosis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower limb fracture
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Spinal compression fracture
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula site haematoma
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Contusion
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematoma
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pubis fracture
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incisional hernia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint dislocation
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon rupture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tibia fracture
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
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
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper limb fracture
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia postoperative
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass thrombosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Forearm fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ulna fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft complication
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular pseudoaneurysm
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical vertebral fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Concussion
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial bones fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal dialysis complication
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thoracic vertebral fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acetabulum fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Craniocerebral injury
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Fibula fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Foot fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal stoma complication
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Laceration
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle rupture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perirenal haematoma
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post-traumatic pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subdural haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Thermal burn
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound dehiscence
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound necrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wrist fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft aneurysm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site haematoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Burns second degree
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clavicle fracture
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery restenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extradural haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Face injury
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament rupture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Patella fracture
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative hernia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural complication
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt aneurysm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Shunt stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin wound
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal fracture
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haematoma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft occlusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular graft thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wound dehiscence
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arterial bypass occlusion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous fistula occlusion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Avulsion fracture
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone contusion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone fissure
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain contusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carbon monoxide poisoning
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac valve replacement complication
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chest injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplant surgery
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Complications of transplanted kidney
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device deployment issue
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dislocation of vertebra
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eschar
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Extensive interdialytic weight gain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal anastomotic leak
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemodialysis complication
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyphaema
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated incisional hernia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intentional overdose
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal anastomosis complication
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ligament sprain
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney rupture
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lip injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Multiple injuries
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Muscle strain
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periorbital haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral artery restenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural complication
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural haematuria
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative delirium
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative ileus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postpericardiotomy syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural dizziness
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural hypertension
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Procedural pneumothorax
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Radiation proctitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skull fractured base
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stoma site haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stomal hernia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tendon injury
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic coma
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Traumatic haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic haemothorax
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Traumatic intracranial haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Vascular access complication
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular bypass dysfunction
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasoplegia syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
|
|
Congenital cystic kidney disease
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydrocele
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congenital bladder anomaly
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nonketotic hyperglycinaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Phimosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorders
|
|
|
Acute myocardial infarction
|
|
|
subjects affected / exposed
|
63 / 1409 (4.47%) |
74 / 1409 (5.25%) |
occurrences causally related to treatment / all
|
3 / 82 |
3 / 94 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 17 |
Atrial fibrillation
|
|
|
subjects affected / exposed
|
49 / 1409 (3.48%) |
57 / 1409 (4.05%) |
occurrences causally related to treatment / all
|
0 / 58 |
0 / 66 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Myocardial infarction
|
|
|
subjects affected / exposed
|
54 / 1409 (3.83%) |
50 / 1409 (3.55%) |
occurrences causally related to treatment / all
|
4 / 62 |
1 / 54 |
deaths causally related to treatment / all
|
1 / 25 |
0 / 16 |
Cardiac arrest
|
|
|
subjects affected / exposed
|
55 / 1409 (3.90%) |
44 / 1409 (3.12%) |
occurrences causally related to treatment / all
|
1 / 55 |
0 / 45 |
deaths causally related to treatment / all
|
1 / 52 |
0 / 37 |
Angina pectoris
|
|
|
subjects affected / exposed
|
35 / 1409 (2.48%) |
37 / 1409 (2.63%) |
occurrences causally related to treatment / all
|
0 / 37 |
1 / 46 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Cardiac failure
|
|
|
subjects affected / exposed
|
25 / 1409 (1.77%) |
34 / 1409 (2.41%) |
occurrences causally related to treatment / all
|
0 / 31 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 12 |
0 / 13 |
Acute coronary syndrome
|
|
|
subjects affected / exposed
|
29 / 1409 (2.06%) |
25 / 1409 (1.77%) |
occurrences causally related to treatment / all
|
0 / 32 |
0 / 30 |
deaths causally related to treatment / all
|
0 / 7 |
0 / 2 |
Cardiac failure congestive
|
|
|
subjects affected / exposed
|
20 / 1409 (1.42%) |
24 / 1409 (1.70%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 26 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 4 |
Coronary artery disease
|
|
|
subjects affected / exposed
|
20 / 1409 (1.42%) |
24 / 1409 (1.70%) |
occurrences causally related to treatment / all
|
1 / 22 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Angina unstable
|
|
|
subjects affected / exposed
|
24 / 1409 (1.70%) |
16 / 1409 (1.14%) |
occurrences causally related to treatment / all
|
1 / 26 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocardial ischaemia
|
|
|
subjects affected / exposed
|
17 / 1409 (1.21%) |
21 / 1409 (1.49%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 6 |
Bradycardia
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
20 / 1409 (1.42%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Cardio-respiratory arrest
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
12 / 1409 (0.85%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 12 |
deaths causally related to treatment / all
|
1 / 8 |
0 / 9 |
Aortic valve stenosis
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrioventricular block complete
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Coronary artery stenosis
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiogenic shock
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 7 |
Atrial flutter
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac failure acute
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cardiopulmonary failure
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 6 |
0 / 3 |
Ventricular fibrillation
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 2 |
Arrhythmia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Left ventricular failure
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cardiac failure chronic
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Sinus node dysfunction
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachycardia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrial tachycardia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atrioventricular block second degree
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericardial effusion
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sinus bradycardia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Acute left ventricular failure
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arteriosclerosis coronary artery
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Atrial thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bradyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery thrombosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Ischaemic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Right ventricular failure
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tachyarrhythmia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve disease mixed
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
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
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac disorder
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Congestive cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery insufficiency
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitral valve incompetence
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pericarditis uraemic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulseless electrical activity
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sinus tachycardia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Supraventricular tachycardia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular extrasystoles
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Adams-Stokes syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aortic valve incompetence
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bundle branch block left
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac dysfunction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiac tamponade
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cardiovascular insufficiency
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Chordae tendinae rupture
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Conduction disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery dissection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Coronary artery occlusion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Extrasystoles
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve incompetence
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Heart valve stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive heart disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Low cardiac output syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mitral valve stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myocarditis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Palpitations
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paroxysmal atrioventricular block
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Sinoatrial block
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Stress cardiomyopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Tachycardia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torsade de pointes
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tricuspid valve incompetence
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular dyssynchrony
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ventricular tachyarrhythmia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorders
|
|
|
Ischaemic stroke
|
|
|
subjects affected / exposed
|
21 / 1409 (1.49%) |
28 / 1409 (1.99%) |
occurrences causally related to treatment / all
|
1 / 23 |
1 / 29 |
deaths causally related to treatment / all
|
1 / 5 |
0 / 3 |
Transient ischaemic attack
|
|
|
subjects affected / exposed
|
30 / 1409 (2.13%) |
17 / 1409 (1.21%) |
occurrences causally related to treatment / all
|
2 / 31 |
0 / 21 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular accident
|
|
|
subjects affected / exposed
|
24 / 1409 (1.70%) |
23 / 1409 (1.63%) |
occurrences causally related to treatment / all
|
0 / 27 |
4 / 26 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 4 |
Syncope
|
|
|
subjects affected / exposed
|
15 / 1409 (1.06%) |
22 / 1409 (1.56%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haemorrhage
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 5 |
Seizure
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral infarction
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Dizziness
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Carpal tunnel syndrome
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ischaemia
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Haemorrhagic stroke
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 3 |
Haemorrhage intracranial
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
1 / 5 |
deaths causally related to treatment / all
|
0 / 4 |
0 / 2 |
Dementia
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sciatica
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epilepsy
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Headache
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic encephalopathy
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Carotid artery stenosis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vascular dementia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular disorder
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Presyncope
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic stroke
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Altered state of consciousness
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia Alzheimer's type
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paralysis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypertensive encephalopathy
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Stupor
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Aphasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ataxia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain stem infarction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyskinesia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Embolic stroke
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Generalised tonic-clonic seizure
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic coma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoxic-ischaemic encephalopathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intracranial aneurysm
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intraventricular haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Lacunar infarction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peripheral sensorimotor neuropathy
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyneuropathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Posterior reversible encephalopathy syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Trigeminal neuralgia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Balance disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Brain hypoxia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Brain injury
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cauda equina syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebellar stroke
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral ataxia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebral arteriosclerosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Cerebral small vessel ischaemic disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cerebrovascular insufficiency
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cervical radiculopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cognitive disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dementia with Lewy bodies
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Demyelination
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
1 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Depressed level of consciousness
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic mononeuropathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic neuropathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Essential tremor
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Facial paresis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Guillain-Barre syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemianopia homonymous
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hemiparesis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemic seizure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic seizure
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoglycaemic unconsciousness
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IIIrd nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic cerebral infarction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic neuropathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
IVth nerve paresis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lacunar stroke
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lethargy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Loss of consciousness
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Memory impairment
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic encephalopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Migraine
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Monoparesis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Movement disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myelopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myoclonic epilepsy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nerve root compression
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nervous system disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Noninfective encephalitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Paraparesis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retrograde amnesia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reversible ischaemic neurological deficit
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Somnolence
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal subarachnoid haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Status epilepticus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tension headache
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thalamus haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Transient global amnesia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Unresponsive to stimuli
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
VIth nerve paralysis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wallerian degeneration
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Blood and lymphatic system disorders
|
|
|
Anaemia
|
|
|
subjects affected / exposed
|
25 / 1409 (1.77%) |
22 / 1409 (1.56%) |
occurrences causally related to treatment / all
|
1 / 27 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemolysis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
1 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombocytopenia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow failure
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anaemia of chronic disease
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anaemia of malignant disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated intravascular coagulation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Lymphadenopathy
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephrogenic anaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haematoma
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Thrombotic thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone marrow toxicity
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile bone marrow aplasia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemolytic anaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic anaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Histiocytosis haematophagic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Immune thrombocytopenic purpura
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neutropenia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Normochromic anaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancytopenia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polycythaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
1 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Splenic infarction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spontaneous haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sudden hearing loss
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute vestibular syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Deafness unilateral
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertigo labyrinthine
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Eye disorders
|
|
|
Cataract
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glaucoma
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic retinopathy
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal artery occlusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cataract diabetic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine ophthalmopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ocular vasculitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Optic ischaemic neuropathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Papilloedema
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal neovascularisation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retinal vein thrombosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vision blurred
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Visual impairment
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vitreous haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
24 / 1409 (1.70%) |
23 / 1409 (1.63%) |
occurrences causally related to treatment / all
|
0 / 26 |
1 / 27 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Abdominal pain
|
|
|
subjects affected / exposed
|
13 / 1409 (0.92%) |
16 / 1409 (1.14%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diarrhoea
|
|
|
subjects affected / exposed
|
18 / 1409 (1.28%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine polyp
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 9 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal haemorrhage
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 11 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Constipation
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric ulcer
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Inguinal hernia
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ischaemic
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 3 |
Gastric ulcer haemorrhage
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Intestinal ischaemia
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 5 |
Intestinal obstruction
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Melaena
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Colitis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pancreatitis acute
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Duodenal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal pain upper
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis erosive
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastritis haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhoidal haemorrhage
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diverticulum
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Enteritis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Small intestinal obstruction
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Vomiting
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiodysplasia haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematemesis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haemorrhoids
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal infarction
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Gastrointestinal disorder
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematochezia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mallory-Weiss syndrome
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic gastritis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenal ulcer
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dyspepsia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrooesophageal reflux disease
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Incarcerated inguinal hernia
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestine perforation
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Abdominal discomfort
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subileus
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haematoma
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute abdomen
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Anal fistula
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastroparesis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Encapsulating peritoneal sclerosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastric antral vascular ectasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal angiectasia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal polyp haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhagic erosive gastritis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileus
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Large intestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising colitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis necrotising
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Peptic ulcer haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal prolapse
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal hernia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ascites
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis erosive
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dental caries
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum intestinal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocutaneous fistula
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive duodenitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erosive oesophagitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Food poisoning
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal necrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal ulcer haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
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
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Incarcerated umbilical hernia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal perforation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal polyp
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Large intestinal ulcer
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lower gastrointestinal haemorrhage
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pancreatitis chronic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritoneal perforation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rectal polyp
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall haemorrhage
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal fissure
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal ulcer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anorectal varices
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal mucocoele
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colitis ulcerative
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Defaecation urgency
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gastropathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticular perforation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulum oesophageal
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Duodenitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterocolitis haemorrhagic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Faecaloma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flatulence
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gallstone ileus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroduodenal ulcer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal hypomotility
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ileal perforation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Inguinal hernia strangulated
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal angina
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal mass
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal pseudo-obstruction
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal varices
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intra-abdominal fluid collection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic enteritis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Large intestinal stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar hernia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mesenteric arterial occlusion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nausea
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal spasm
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophageal ulcer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oesophagitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oral disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peptic ulcer perforation
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Reflux gastritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salivary gland enlargement
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tongue oedema
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Umbilical hernia, obstructive
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varices oesophageal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Volvulus
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Strangulated umbilical hernia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin and subcutaneous tissue disorders
|
|
|
Skin ulcer
|
|
|
subjects affected / exposed
|
17 / 1409 (1.21%) |
17 / 1409 (1.21%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 18 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Diabetic foot
|
|
|
subjects affected / exposed
|
11 / 1409 (0.78%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
0 / 13 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Skin necrosis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ischaemic skin ulcer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug eruption
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Decubitus ulcer
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erythema
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Panniculitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyoderma gangrenosum
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Stasis dermatitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute generalised exanthematous pustulosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholestatic pruritus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermal cyst
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dermatitis exfoliative
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ulcer
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Drug reaction with eosinophilia and systemic symptoms
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Erythema multiforme
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Henoch-Schonlein purpura
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperkeratosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic ulcer
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Psoriasis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin erosion
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin lesion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urticaria
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vasculitic rash
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal and urinary disorders
|
|
|
End stage renal disease
|
|
|
subjects affected / exposed
|
26 / 1409 (1.85%) |
31 / 1409 (2.20%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 31 |
deaths causally related to treatment / all
|
0 / 26 |
0 / 29 |
Renal impairment
|
|
|
subjects affected / exposed
|
18 / 1409 (1.28%) |
20 / 1409 (1.42%) |
occurrences causally related to treatment / all
|
2 / 18 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Haematuria
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Azotaemia
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute kidney injury
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Nephrolithiasis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst haemorrhage
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hydronephrosis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal failure
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Renal colic
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary retention
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureteric stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ureterolithiasis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder polyp
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bladder tamponade
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calculus urethral
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis haemorrhagic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis interstitial
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Glomerulonephritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemorrhage urinary tract
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Kidney enlargement
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lupus nephritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition-inflammation-atherosclerosis syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Nephritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nephropathy toxic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Proteinuria
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal artery stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal cyst ruptured
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal haematoma
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal ischaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Urethral stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary bladder haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract obstruction
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocrine disorders
|
|
|
Hyperparathyroidism secondary
|
|
|
subjects affected / exposed
|
23 / 1409 (1.63%) |
19 / 1409 (1.35%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 19 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism tertiary
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperparathyroidism
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Adrenal insufficiency
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Goitre
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypothyroidism
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Basedow's disease
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parathyroid hyperplasia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal and connective tissue disorders
|
|
|
Osteoarthritis
|
|
|
subjects affected / exposed
|
16 / 1409 (1.14%) |
19 / 1409 (1.35%) |
occurrences causally related to treatment / all
|
0 / 17 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal chest pain
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Back pain
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthralgia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
6 / 1409 (0.43%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral disc protrusion
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bursitis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteitis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal osteoarthritis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscular weakness
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic lupus erythematosus
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gouty arthritis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemarthrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lumbar spinal stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pathological fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polymyalgia rheumatica
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rhabdomyolysis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spinal column stenosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Synovitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint effusion
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neuropathic arthropathy
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteolysis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteonecrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteoporotic fracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotator cuff syndrome
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthrofibrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthropathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chondropathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic kidney disease-mineral and bone disorder
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Collagen disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Compartment syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dupuytren's contracture
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fibromyalgia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Flank pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
High turnover osteopathy
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle haemorrhage
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle necrosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Musculoskeletal pain
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myalgia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Myositis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Neck pain
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pain in extremity
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Plantar fasciitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Polyarthritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rheumatoid arthritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sarcopenia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Soft tissue necrosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Spondylitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Sympathetic posterior cervical syndrome
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Torticollis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vertebral foraminal stenosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infections and infestations
|
|
|
Pneumonia
|
|
|
subjects affected / exposed
|
180 / 1409 (12.78%) |
163 / 1409 (11.57%) |
occurrences causally related to treatment / all
|
1 / 228 |
0 / 205 |
deaths causally related to treatment / all
|
0 / 27 |
0 / 19 |
Sepsis
|
|
|
subjects affected / exposed
|
69 / 1409 (4.90%) |
85 / 1409 (6.03%) |
occurrences causally related to treatment / all
|
0 / 79 |
1 / 96 |
deaths causally related to treatment / all
|
0 / 26 |
1 / 39 |
Peritonitis
|
|
|
subjects affected / exposed
|
47 / 1409 (3.34%) |
46 / 1409 (3.26%) |
occurrences causally related to treatment / all
|
0 / 62 |
0 / 70 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Septic shock
|
|
|
subjects affected / exposed
|
36 / 1409 (2.56%) |
49 / 1409 (3.48%) |
occurrences causally related to treatment / all
|
0 / 36 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 27 |
0 / 34 |
Gastroenteritis
|
|
|
subjects affected / exposed
|
39 / 1409 (2.77%) |
27 / 1409 (1.92%) |
occurrences causally related to treatment / all
|
0 / 49 |
0 / 27 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection
|
|
|
subjects affected / exposed
|
31 / 1409 (2.20%) |
33 / 1409 (2.34%) |
occurrences causally related to treatment / all
|
0 / 35 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Device related sepsis
|
|
|
subjects affected / exposed
|
21 / 1409 (1.49%) |
30 / 1409 (2.13%) |
occurrences causally related to treatment / all
|
0 / 29 |
0 / 36 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 3 |
Lower respiratory tract infection
|
|
|
subjects affected / exposed
|
21 / 1409 (1.49%) |
28 / 1409 (1.99%) |
occurrences causally related to treatment / all
|
0 / 26 |
0 / 37 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Cellulitis
|
|
|
subjects affected / exposed
|
22 / 1409 (1.56%) |
25 / 1409 (1.77%) |
occurrences causally related to treatment / all
|
0 / 25 |
0 / 28 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Device related infection
|
|
|
subjects affected / exposed
|
19 / 1409 (1.35%) |
28 / 1409 (1.99%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 38 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis
|
|
|
subjects affected / exposed
|
20 / 1409 (1.42%) |
24 / 1409 (1.70%) |
occurrences causally related to treatment / all
|
0 / 22 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gangrene
|
|
|
subjects affected / exposed
|
22 / 1409 (1.56%) |
20 / 1409 (1.42%) |
occurrences causally related to treatment / all
|
0 / 24 |
0 / 23 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Respiratory tract infection
|
|
|
subjects affected / exposed
|
16 / 1409 (1.14%) |
23 / 1409 (1.63%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Staphylococcal sepsis
|
|
|
subjects affected / exposed
|
14 / 1409 (0.99%) |
18 / 1409 (1.28%) |
occurrences causally related to treatment / all
|
0 / 16 |
0 / 20 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 1 |
Urosepsis
|
|
|
subjects affected / exposed
|
19 / 1409 (1.35%) |
11 / 1409 (0.78%) |
occurrences causally related to treatment / all
|
0 / 20 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 5 |
0 / 1 |
Bacteraemia
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
14 / 1409 (0.99%) |
occurrences causally related to treatment / all
|
0 / 11 |
0 / 14 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Arteriovenous fistula site infection
|
|
|
subjects affected / exposed
|
9 / 1409 (0.64%) |
14 / 1409 (0.99%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infection
|
|
|
subjects affected / exposed
|
15 / 1409 (1.06%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 15 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Upper respiratory tract infection
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 12 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic foot infection
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 14 |
0 / 15 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
13 / 1409 (0.92%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 16 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Erysipelas
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
1 / 12 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Endocarditis
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 2 |
Catheter site infection
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative wound infection
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
10 / 1409 (0.71%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal bacteraemia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arteriovenous graft site infection
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Arthritis bacterial
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected skin ulcer
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 10 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lung infection
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
8 / 1409 (0.57%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 8 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Viral infection
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
1 / 8 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyelonephritis acute
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound infection
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia sepsis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Localised infection
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pneumonia bacterial
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pulmonary sepsis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
7 / 1409 (0.50%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 7 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 4 |
Staphylococcal infection
|
|
|
subjects affected / exposed
|
8 / 1409 (0.57%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 8 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Influenza
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonitis bacterial
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile colitis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes zoster
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Necrotising fasciitis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Renal cyst infection
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendicitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial sepsis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
5 / 1409 (0.35%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Cystitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic gangrene
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterococcal sepsis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Infective exacerbation of chronic obstructive airways disease
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abdominal abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 5 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Abscess limb
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Anal abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diverticulitis intestinal haemorrhagic
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious colitis
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infectious pleural effusion
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomonal sepsis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Soft tissue infection
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Biliary sepsis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fungal peritonitis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Gastroenteritis viral
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Graft infection
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
H1N1 influenza
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective exacerbation of bronchiectasis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Ophthalmic herpes zoster
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pseudomembranous colitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Pyelonephritis chronic
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Acute sinusitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis gangrenous
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cholangitis infective
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
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
|
3 / 1409 (0.21%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis clostridial
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intervertebral discitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia staphylococcal
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Post procedural sepsis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Pyonephrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Septic necrosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Sialoadenitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal sepsis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subcutaneous abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tonsillitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Wound sepsis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Abdominal sepsis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Appendicitis perforated
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Arteriosclerotic gangrene
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
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
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Clostridium difficile infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diarrhoea infectious
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Empyema
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 0 |
Encephalitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis bacterial
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endocarditis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enterobacter sepsis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epididymitis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Epiglottitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Fungal oesophagitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis salmonella
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Groin abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haematoma infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemophilus infection
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Joint tuberculosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella sepsis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Listeriosis
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lymph node tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis chronic
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumococcal sepsis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Pneumonia klebsiella
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Proteus infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pulmonary tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Renal graft infection
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Retroperitoneal abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Septic arthritis staphylococcal
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 2 |
Sinusitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal skin infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Skin bacterial infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Streptococcal bacteraemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Systemic candida
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection enterococcal
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Viral upper respiratory tract infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Abdominal wall infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Appendiceal abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Atypical mycobacterial infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bacterial colitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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 / 1409 (0.07%) |
0 / 1409 (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
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bone tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchitis viral
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Bronchopulmonary aspergillosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Campylobacter gastroenteritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cat scratch disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Catheter site abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cellulitis staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Chronic tonsillitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Citrobacter sepsis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Colon gangrene
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corneal abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Corynebacterium sepsis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Cystitis bacterial
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Dacryocystitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Disseminated tuberculosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Endophthalmitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Enteritis infectious
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia pyelonephritis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Escherichia urinary tract infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Febrile infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis bacterial
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastroenteritis norovirus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gastrointestinal infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Genitourinary tract infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hepatic cyst infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Herpes sepsis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Herpes zoster meningoencephalitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Implant site infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected bunion
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected dermal cyst
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infected fistula
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Infective gastroduodenitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Injection site infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Intestinal fistula infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Joint abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Klebsiella infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Listeria encephalitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Liver abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Lung abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mesenteric abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Muscle abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Mycetoma mycotic
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nail infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nasopharyngitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Nosocomial infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Oropharyngeal candidiasis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Osteomyelitis acute
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis externa
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Otitis media acute
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Parotitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pelvic inflammatory disease
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Perihepatic abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontitis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Periodontal destruction
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Peritonsillar abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia legionella
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pharyngitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia necrotising
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia pneumococcal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (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 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pneumonia respiratory syncytial viral
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Postoperative abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Pyomyositis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Renal abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Respiratory syncytial virus infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Rotavirus infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salmonellosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Salpingitis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Seminal vesicle abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Skin infection
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Staphylococcal abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Subacute endocarditis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tooth abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Tubo-ovarian abscess
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urethral abscess
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Urinary tract infection staphylococcal
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Vaginal infection
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Varicella
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolism and nutrition disorders
|
|
|
Fluid overload
|
|
|
subjects affected / exposed
|
43 / 1409 (3.05%) |
44 / 1409 (3.12%) |
occurrences causally related to treatment / all
|
1 / 52 |
0 / 50 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 0 |
Hyperkalaemia
|
|
|
subjects affected / exposed
|
32 / 1409 (2.27%) |
18 / 1409 (1.28%) |
occurrences causally related to treatment / all
|
0 / 42 |
0 / 25 |
deaths causally related to treatment / all
|
0 / 1 |
0 / 1 |
Hypoglycaemia
|
|
|
subjects affected / exposed
|
17 / 1409 (1.21%) |
12 / 1409 (0.85%) |
occurrences causally related to treatment / all
|
0 / 19 |
0 / 13 |
deaths causally related to treatment / all
|
0 / 2 |
0 / 1 |
Cachexia
|
|
|
subjects affected / exposed
|
10 / 1409 (0.71%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 10 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 10 |
0 / 7 |
Hyperglycaemia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
9 / 1409 (0.64%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 9 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 1 |
Dehydration
|
|
|
subjects affected / exposed
|
7 / 1409 (0.50%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 7 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus inadequate control
|
|
|
subjects affected / exposed
|
5 / 1409 (0.35%) |
3 / 1409 (0.21%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 6 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypocalcaemia
|
|
|
subjects affected / exposed
|
6 / 1409 (0.43%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 6 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Malnutrition
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
4 / 1409 (0.28%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 4 |
deaths causally related to treatment / all
|
0 / 3 |
0 / 0 |
Hypervolaemia
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 4 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Calciphylaxis
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic complication
|
|
|
subjects affected / exposed
|
4 / 1409 (0.28%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 5 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypercalcaemia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetes mellitus
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyponatraemia
|
|
|
subjects affected / exposed
|
3 / 1409 (0.21%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 3 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Gout
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Electrolyte imbalance
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypokalaemia
|
|
|
subjects affected / exposed
|
2 / 1409 (0.14%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hyperinsulinaemic hypoglycaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
2 / 1409 (0.14%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 2 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypovolaemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 2 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Decreased appetite
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic ketoacidosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 3 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Diabetic metabolic decompensation
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Fluid retention
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Haemochromatosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypoalbuminaemia
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Hypophosphataemia
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Lactic acidosis
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic acidosis
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Metabolic disorder
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Mitochondrial cytopathy
|
|
|
subjects affected / exposed
|
0 / 1409 (0.00%) |
1 / 1409 (0.07%) |
occurrences causally related to treatment / all
|
0 / 0 |
0 / 1 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Obesity
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 1 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |
Type 1 diabetes mellitus
|
|
|
subjects affected / exposed
|
1 / 1409 (0.07%) |
0 / 1409 (0.00%) |
occurrences causally related to treatment / all
|
0 / 2 |
0 / 0 |
deaths causally related to treatment / all
|
0 / 0 |
0 / 0 |